Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-28 @ 7:15 PM
Study NCT ID:
NCT02105168
Status:
UNKNOWN
Last Update Posted:
2016-06-10
First Post:
2014-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-09', 'studyFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mutation rate on tumorous material', 'timeFrame': 'Assessed at the time of inclusion', 'description': 'Assessed at the time of inclusion using tumorous material used for diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Melanoma', 'Non Small Cell Lung Cancer', 'Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '34022698', 'type': 'DERIVED', 'citation': 'Mezquita L, Preeshagul I, Auclin E, Saravia D, Hendriks L, Rizvi H, Park W, Nadal E, Martin-Romano P, Ruffinelli JC, Ponce S, Audigier-Valette C, Carnio S, Blanc-Durand F, Bironzo P, Tabbo F, Reale ML, Novello S, Hellmann MD, Sawan P, Girshman J, Plodkowski AJ, Zalcman G, Majem M, Charrier M, Naigeon M, Rossoni C, Mariniello A, Paz-Ares L, Dingemans AM, Planchard D, Cozic N, Cassard L, Lopes G, Chaput N, Arbour K, Besse B. Predicting immunotherapy outcomes under therapy in patients with advanced NSCLC using dNLR and its early dynamics. Eur J Cancer. 2021 Jul;151:211-220. doi: 10.1016/j.ejca.2021.03.011. Epub 2021 May 19.'}]}, 'descriptionModule': {'briefSummary': 'Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cytological or histological diagnosis of SCLC, NSCLC or melanoma\n2. Patients age \\>/= 18 years old\n3. Indication of treatment using platinum salts for lung cancer except for patient with NSCLC treated by surgery for whom platinum salts is not indicated\n4. If a biopsy is proposed, lesion lust be easily accessible\n5. Signed informed consent\n\nExclusion Criteria:\n\n1. Patients unable to follow the protocol\n2. Consent refusal'}, 'identificationModule': {'nctId': 'NCT02105168', 'acronym': 'MSN', 'briefTitle': 'Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment in Patients With Lung Cancer or Melanoma', 'orgStudyIdInfo': {'id': '2008-A00373-52'}, 'secondaryIdInfos': [{'id': '2007/1363', 'type': 'OTHER', 'domain': 'CSET number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'Blood sample Tumorous biopsy Healthy material sample', 'interventionNames': ['Procedure: Blood sample', 'Procedure: Tumorous biopsy', 'Procedure: Healthy material sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'PROCEDURE', 'description': 'Optional', 'armGroupLabels': ['Experimental arm']}, {'name': 'Tumorous biopsy', 'type': 'PROCEDURE', 'description': 'Optional', 'armGroupLabels': ['Experimental arm']}, {'name': 'Healthy material sample', 'type': 'PROCEDURE', 'description': 'Optional', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94805', 'city': 'Villejuif', 'state': 'Val de Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin Besse, MD', 'role': 'CONTACT', 'email': 'benjamin.besse@gustaveroussy.fr', 'phone': '0142114317', 'phoneExt': '+33'}, {'name': 'Caroline Robert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gustave Roussy Cancer Campus Grand Paris', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Benjamin Besse, MD', 'role': 'CONTACT', 'email': 'benjamin.besse@gustaveroussy.fr', 'phone': '0142114317', 'phoneExt': '+33'}, {'name': 'Caroline Robert, MD', 'role': 'CONTACT', 'email': 'caroline.robert@gustaveroussy.fr', 'phone': '0142114211', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Benjamin Besse, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}