Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-12 @ 12:17 AM
Study NCT ID:
NCT02828202
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2015-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Primary melanoma (mostly paraffin embedded), metastatic sample (s)(paraffin embedded and frozen) from at least 1 site at inclusion and during evolution (particularly before treatment modification if clinically required, DNA and RNA from peripheral blood mononuclear cells, plasma, serum, peripheral blood mononuclear cells sampled at inclusion, every 6 months and before each new systemic therapy during 3 years.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2015-10-20', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '10 years', 'description': 'With a Kaplan-Meier curve analysis and Cox model'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': '10 years', 'description': 'With a Kaplan-Meier curve analysis and Cox model'}, {'measure': 'Overall response', 'timeFrame': '10 years', 'description': 'Determined by tumor assessments'}, {'measure': 'Nature and incidence of Treatment-Emergent Adverse Events (Safety)', 'timeFrame': '10 years', 'description': 'Evaluated with CTCAE v4.0 or v5.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Melanoma', 'Skin', 'Biobank'], 'conditions': ['Malignant Melanoma']}, 'referencesModule': {'references': [{'pmid': '35288462', 'type': 'DERIVED', 'citation': 'Plaschka M, Benboubker V, Grimont M, Berthet J, Tonon L, Lopez J, Le-Bouar M, Balme B, Tondeur G, de la Fouchardiere A, Larue L, Puisieux A, Grinberg-Bleyer Y, Bendriss-Vermare N, Dubois B, Caux C, Dalle S, Caramel J. ZEB1 transcription factor promotes immune escape in melanoma. J Immunother Cancer. 2022 Mar;10(3):e003484. doi: 10.1136/jitc-2021-003484.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33385520/', 'label': 'Di Filippo Y. et al., Relevance of body mass index as a predictor of systemic therapy outcomes in metastatic melanoma: analysis of the MelBase French cohort data; Ann Oncol . 2021 Apr;32(4):542-551. doi: 10.1016/j.annonc.2020.12.012.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30384014/', 'label': 'Kandel M. et al., Update of survival and cost of metastatic melanoma with new drugs: Estimations from the MelBase cohort ; Eur J Cancer . 2018 Dec;105:33-40. doi: 10.1016/j.ejca.2018.09.026.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/31042256/', 'label': 'Vallet A. et al., Association of Time From Primary Diagnosis to First Distant Relapse of Metastatic Melanoma With Progression of Disease and Survival ; JAMA Dermatol . 2019 Jun 1;155(6):673-678. doi: 10.1001/jamadermatol.2019.0425.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30909072/', 'label': 'Tetu et al.Impact of radiotherapy administered simultaneously with systemic treatment in patients with melanoma brain metastases within MelBase, a French multicentric prospective cohort; Eur J Cancer 2019 May;112:38-46'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/31639198/', 'label': 'Kandel M et al., Quality-of-life assessment in French patients with metastatic melanoma in real life; Cancer . 2020 Feb 1;126(3):611-618. doi: 10.1002/cncr.32554.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32585901/', 'label': 'Huynh S. et al., Combined Therapy with Anti-PD1 and BRAF and/or MEK Inhibitor for Advanced Melanoma: A Multicenter Cohort Study; Cancers (Basel) . 2020 Jun 23;12(6):1666. doi: 10.3390/cancers12061666'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/34153388/', 'label': 'Carlet C. et al., Late-onset adverse events of anti-PD1 therapy in melanoma patients: An observational study from MELBASE, a nationwide prospective cohort; J Am Acad Dermatol . 2022 Feb;86(2):345-352. doi: 10.1016/j.jaad.2021.06.849'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/34074114/', 'label': 'Casarotto E. et al., Real-world effectiveness of pembrolizumab in advanced melanoma: analysis of a French national clinicobiological database ; Immunotherapy . 2021 Aug;13(11):905-916. doi: 10.2217/imt-2021-0077'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/34207200/', 'label': 'Becquart O. et al., Tolerance and Effectiveness of Targeted Therapies in Aged Patients with Metastatic Melanoma ; Cancers (Basel) . 2021 Jun 18;13(12):3042. doi: 10.3390/cancers13123042.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/36356284/', 'label': 'Girod M. et al., Non-V600E/K BRAF Mutations in Metastatic Melanoma: Molecular Description, Frequency, and Effectiveness of Targeted Therapy in a Large National Cohort ; JCO Precis Oncol . 2022 Nov;6:e2200075. doi: 10.1200/PO.22.00075.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/35788496/', 'label': 'Placais L. et al.,Risk of irAEs in patients with autoimmune diseases treated by immune checkpoint inhibitors for stage III or IV melanoma: results from a matched case-control study; Ann Rheum Dis 2022 Oct;81(10):1445-1452. doi: 10.1136/ard-2022-222186'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/36543626/', 'label': 'Rousset P. et al., Impact of systemic therapies in metastatic melanoma of unknown primary: A study from MELBASE, a French multicentric prospective cohort; J Am Acad Dermatol . 2023 Apr;88(4):808-815. doi: 10.1016/j.jaad.2022.11.040'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/36547139/', 'label': 'Kandel M. et al., Cost-Effectiveness Analysis of Sequential Treatment Strategies for Advanced Melanoma in Real Life in France'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/37936607/', 'label': 'Russo D. et al., Differential gradients of immunotherapy vs targeted therapy efficacy according to the sun-exposure pattern of the site of occurrence of primary melanoma: a multicenter prospective cohort study (MelBase)'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/37690179/', 'label': 'Fournier M. et al., Hyperprogression in advanced melanoma is not restricted to immunotherapy'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/39527777/', 'label': 'Macaire C. et al., Real-life effectiveness on overall survival of continued immune checkpoint inhibition following progression in advanced melanoma: estimation from the Melbase cohort'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/39717261/', 'label': 'Amiot M. et al., When to stop immunotherapy for advanced melanoma: the emulated target trials'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/39605282/', 'label': 'Billard K. et al., The efficacy and safety of first-line metastatic melanoma treatment with ipilimumab + nivolumab versus nivolumab in a real-world setting'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/39645590/', 'label': "Campo Le Brun I. et al., Methods of nivolumab administration in advanced melanoma: A comparison of patients' clinical outcomes treated with flat dose or weight-adjusted dose, a multicenter observational study"}]}, 'descriptionModule': {'briefSummary': 'Prevention of melanoma can be efficient but mortality remains unchanged and 15 to 20% of patients still die from melanoma. Indeed metastatic melanoma is a heterogeneous highly and multiple mutations driven cancer. Significant survival benefit was demonstrated since 2011 with anti-CTLA4 +/- programmed death-1 (anti PD1) antibodies, B-Raf proto-oncogene, serine/threonine kinase (BRAF) and MAP-ERK kinase (MEK) inhibitors. Future improvement of advanced melanoma prognosis will rely on clinico-epidemiological studies and on biological studies to validate and identify new prognostic and predictive factors based on clinico-epidemiological and histological data, genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile and functional imaging. In the context of marketing of costly innovative molecules, prospective collection of economic data on treatment and toxicity are required. Large biobanks collecting data from cohorts of advanced melanoma are mandatory for such projects.\n\nMELBASE is a French prospective national cohort enrolling advanced melanoma patients whose objectives are to :\n\n* provide an annual instrument panel with descriptive and correlative analysis of advanced melanoma patients in France including epidemiological, clinical, biological and economic characteristics\n* validate and identify new clinical, epidemiological, and biological prognostic factors such as genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile in advanced melanoma\n* evaluate the risk-benefit, quality of life, the management cost of patients treated with validated and future treatments. The project also aims to define predictive biomarkers of response and toxicity including pharmacogenetics and tumor genetics alterations, tumor microenvironment characteristics, individual immunological profile.\n\nPatients with resectable stage II or III will be enrolled since June 2023 with a 10 years follow-up.\n\nPatients with unresectable stage III or IV (resectable or not) or unresectable primary melanoma will be enrolled prospectively since March 2013 with a 10 years follow-up (up to 6000 patients) from 27 French centers.', 'detailedDescription': 'Melanoma is on of rare cancer with increasing frequency in France. Prevention can be efficient in detecting melanoma with good prognosis but mortality remains unchanged and 15 to 20% of patients still die from melanoma. Indeed metastatic melanoma is a heterogeneous highly and multiple mutations driven cancer which is highly resistant to conventional treatments. Significant survival benefit was demonstrated since 2011 with anti-CTLA4 +/- anti PD1 antibodies and BRAF and MEK inhibitors.\n\nIn 2019, melanoma treatment with anti-PD1 antibodies or BRAFi+MEKi (dabrafenib+trametinib) was approved in stage III patients. Since 2023, in France, pembrolizumab is also approved for stage IIB/IIC melanoma patients ; thus, adjuvant therapy will be generalized without any sentinel lymph node surgery.\n\nIn addition, patients could also be treated by neoadjuvant therapies (pembrolizumab or clinical trial) in case of macroscopique stage III, pauci-metastatic stage IV or in case of rare stage II without surgery.\n\nFuture improvement of advanced melanoma prognosis will rely on clinico-epidemiological or biological studies to validate and identify new prognostic and predictive factors, also based on upon clinico-epidemiological and histological data, genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile and functional imaging. In the context of marketing of costly innovative molecules, an assessment of resource consumption is required, with prospective collection of economic data on treatment and toxicity. Large biobanks collecting data from cohorts of advanced melanoma are mandatory for such projects.\n\nThus, MELBASE is a French national clinical biobank whose objectives are to:\n\n* provide an annual instrument panel with descriptive and correlative analysis of advanced melanoma patients in France including epidemiological, clinical, biological and economic characteristics\n* validate and identify new clinical, epidemiological, and biological prognostic factors such as genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile in advanced melanoma\n* evaluate the risk-benefit, quality of life, the management cost of patients treated with validated and future treatments. If possible, cost-effectiveness ratios will be calculated either in all treated patients or in selected populations of patients (based on clinical or biological criteria, like biomarkers), in order to identify populations where these new therapeutics will be the most cost-effective.\n\nThe project also aims to define predictive biomarkers of response and toxicity including pharmacogenetics and tumor genetics alterations, tumor microenvironment characteristics, individual immunological profile.\n\nPatients with resectable stage II or III will be enrolled since June 2023 with a 10 years follow-up.\n\nPatients with unresectable stage III or IV (resectable or not) or unresectable primary melanoma will be enrolled prospectively since March 2013 with a 10 years follow-up (up to 6000 patients) from 27 French centers.\n\nThe information collected in MELBASE will include clinical constitutional factors, factors linked to primary melanoma, factors linked to previous lymph node involvement, tumor kinetics informations, "American Joint Committee on Cancer" (AJCC) stage at inclusion and after various therapeutic intervention, serological markers, metastatic tumor genotyping (one or more sites, one or more time points), therapeutic interventions (medical, surgical, radiotherapy and palliative strategies) with evaluation of response, tolerance, medical direct costs, impact on quality of life,informations on COVID-19 infection and vaccination, consequences on melanoma treatment, date of death, date of latest news.\n\nA virtual Tumor bank collecting samples (optional) mentions available samples stored each participating centers\' Biological Resource Centers (BRC) : primary melanoma (mostly paraffin embedded), metastatic sample (s)(paraffin embedded and frozen) from at least 1 site at inclusion and during evolution (particularly before treatment modification if clinically required), DNA from peripheral blood mononuclear cells, plasma/serum sampled at inclusion, every 6 months and at each new treatment line during 3 years.\n\nAll date will be collected and organized on a data warehouse to generate clinico-epidemiological reports, analysis and a virtual catalog of biological material.\n\nMELBASE project is consistent with the ethical chart of the hospital tumor banks published by the national French Cancer Institute (INCa). MelBase will also be managed by a chart ensuring each participating center management autonomy and availability of collected data A multidisciplinary scientific advisory board will identify research priorities based on clinical practice and scientific knowledge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Cohort Patients with Resectable stage II or III melanoma.\n2. Cohort Patients With Metastatic Melanoma Stage IV (resectable or not) or Unresectable Stage III or unresectable primary.', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Cohort Patients with Resectable stage II or III\n\n Inclusion Criteria:\n\n Patients diagnosed with resectable stage IIA/IIB/IIC or III melanoma, confirmed by histological exam.\n\n Naïve of systemic treatment for resectable stage II or III. Whose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria).\n\n Aged ≥ 18 years. Consenting to participate (signed informed consent).\n\n Exclusion Criteria:\n\n Patients refusal. Choroid melanoma. Resectable stage 1 melanoma. Stage 4, unresectable primitive or unresectable stage 3 melanoma. Patients under guardianship and under trusteeship.\n2. Cohort patients with Unresectable stage III or stage IV (resectable or not) or unresectable primary:\n\nInclusion Criteria:\n\nPatients diagnosed with an advanced melanoma, confirmed by histological exam. Unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma ; or patients treated by neoadjuvant treatment (exceptional) Naïve of systemic treatment for unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma, except adjuvant treatment.\n\nWhose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria).\n\nAged ≥ 18 years. Consenting to participate (signed informed consent).\n\nExclusion Criteria:\n\nResectable stage 1, 2 or 3 melanoma. Patients refusal. Choroid melanoma. Patients under guardianship and under trusteeship.'}, 'identificationModule': {'nctId': 'NCT02828202', 'acronym': 'MelBase', 'briefTitle': 'Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Constitution of a National Cohort of Patients With Metastatic Melanoma Resectable Stage II or Stage III or IV or Unresectable Primary With the Objective of Setting up Epidemiological Monitoring and Clinico-biological Database, MELBASE', 'orgStudyIdInfo': {'id': 'ID-RCB 2015-A00138-41'}, 'secondaryIdInfos': [{'id': '2011-244', 'type': 'OTHER_GRANT', 'domain': 'National Cancer Institute (INCa)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective cohort Resectable stage II or III', 'description': 'Patients with resectable stage II or III melanoma', 'interventionNames': ['Other: Biological', 'Other: Tissular', 'Other: Quality of life']}, {'label': 'Prospective cohort Unresectable stage III or stage IV (resectable or not) or unresectable primary', 'description': 'Patients with unresectable stage III, or stage IV (resectable or not) or unresectable primary melanoma', 'interventionNames': ['Other: Biological', 'Other: Tissular', 'Other: Quality of life']}], 'interventions': [{'name': 'Biological', 'type': 'OTHER', 'description': 'DNA from peripheral blood mononuclear cells, RNA, plasma, serum sampled at inclusion, every 6 months and before each new systemic therapy.', 'armGroupLabels': ['Prospective cohort Resectable stage II or III', 'Prospective cohort Unresectable stage III or stage IV (resectable or not) or unresectable primary']}, {'name': 'Tissular', 'type': 'OTHER', 'description': 'Primary melanoma (mostly paraffin embedded), metastatic sample (s)(paraffin embedded and frozen) from at least 1 site at inclusion and during evolution, particularly before treatment modification if clinically required.', 'armGroupLabels': ['Prospective cohort Resectable stage II or III', 'Prospective cohort Unresectable stage III or stage IV (resectable or not) or unresectable primary']}, {'name': 'Quality of life', 'type': 'OTHER', 'description': 'Specific questionnaires (FACT-M, EUROQUOL) at inclusion, every 3 months and before each new systemic therapy.', 'armGroupLabels': ['Prospective cohort Resectable stage II or III', 'Prospective cohort Unresectable stage III or stage IV (resectable or not) or unresectable primary']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine Lok, MD, PhD', 'role': 'CONTACT', 'email': 'lok.catherine@chu-amiens.fr'}, {'name': 'Catherine Lok, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jean-Philippe Arnault, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gilles Duverlie, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yves-Edouard Herpe, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Denis Chatelain, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Annecy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie De Quatrebarbes, MD, PhD', 'role': 'CONTACT', 'email': 'jdequatrebarbes@ch-annecygenevois.fr'}, {'name': 'Julie De Quatrebarbes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anne-Claire Bing, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laure Bondier, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pauline Hoelt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthieu Levavasseur, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CH Annecy Genevois', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François Aubin, MD, PhD', 'role': 'CONTACT', 'email': 'francois.aubin@univ-fcomte.fr'}, {'name': 'François Aubin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Severine Valmary-Degano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Charlee Nardin, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '93000', 'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eve Maubec, MD, PhD', 'role': 'CONTACT', 'email': 'eve.maubec@aphp.fr'}, {'name': 'Eve Maubec, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Valentine Heidelberger, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Coralie Zumelzu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Beatrice Villette, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claudia Bejar, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Avicennes', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Bordeaux', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CHU de Bordeaux Hôpital Haut Levêque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline Dutriaux, MD, PhD', 'role': 'CONTACT', 'email': 'caroline.dutriaux@chu-bordeaux.fr'}, {'name': 'Caroline Dutriaux, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sorilla Prey, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'H Conte, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emilie Gerard, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean-Philippe Merlio, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Beatrice Vergier, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre Dubus, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux Hôpital Saint-André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Boulogne-Billancourt', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Delphine Legoupil, MD', 'role': 'CONTACT', 'email': 'delphine.legoupil@chu-brest.fr'}, {'name': 'Delphine Legoupil, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laurent Misery, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claire Abasq, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emilie Brenaut, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pascale Marcorelles, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marie-Cecile Nicot, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ouidad Zehou, MD, PhD', 'role': 'CONTACT', 'email': 'ouidad.zehou@aphp.fr'}, {'name': 'Ouidad Zehou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alice Viarnaud, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arnaud Jannic, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Dalac, MD, PhD', 'role': 'CONTACT', 'email': 'sophie.dalac@chu-dijon.fr'}, {'name': 'Sophie Dalac, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Geraldine Jeudy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marie-Helene Aubriot Lorton, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bertille Bonniaud, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alain Bonnin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Therese Leccia, MD, PhD', 'role': 'CONTACT', 'email': 'mtleccia@chu-grenoble.fr'}, {'name': 'Marie-Therese Leccia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Philippe Lorimier, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicole Pinel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Mortier, MD, PhD', 'role': 'CONTACT', 'email': 'laurent.mortier@chru-lille.fr'}, {'name': 'Laurent Mortier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anna Greliak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dominique Deplanque, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marie-Christine Copin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Philippe Jamme, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': 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'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CLCC Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cecile Pages Laurent, MD, PhD', 'role': 'CONTACT', 'email': 'PagesLaurent.Cecile@iuct-oncopole.fr'}, {'name': 'Sophie Thellier, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marianne Thomas-Pfaab, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cecile Pages Laurent, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre Brousset, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Florian Deilhes, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Celeste Lebbe, MD, PhD', 'role': 'CONTACT', 'email': 'celeste.lebbe@aphp.fr', 'phone': '+33142494679'}, {'name': 'Laetitia Da Meda', 'role': 'CONTACT', 'email': 'laetitia.da-meda@aphp.fr', 'phone': '+33142499392'}], 'overallOfficials': [{'name': 'Celeste Lebbe, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "AP-HP, Hopital Saint-Louis, centre d'oncodermatologie, Paris"}, {'name': 'Gaelle Quereux, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}