Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT02139020
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2014-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'One EDTA tube is collected at the beginning of the study and there are only plasma samples at baseline, during treatment, and at progression.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2033-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2014-05-14', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2033-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prospective storage of plasma samples of patients treated with cetuximab or other targeted agents', 'timeFrame': 'one year after the collection', 'description': 'All the analyses will be done when we have enough of collected samples'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Targeted therapies', 'Plasma samples'], 'conditions': ['Squamous Cell Carcinoma of the Head and Neck']}, 'descriptionModule': {'briefSummary': 'The investigators will collect plasma samples at baseline, during treatment, and at progression.', 'detailedDescription': 'In this study, the investigators will collect plasma samples at baseline, during treatment, and at progression. This plasma bank will be used to study the potential value of some biomarkers to predict treatment activity or resistance to cetuximab or other targeted agents'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'PATIENTS TREATED WITH MOLECULAR TARGETED THERAPIES FOR SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients treated with radiation therapy and cetuximab according to Bonner et al\n* patients treated with cetuximab in combination with chemotherapy according to Vermorken et al.\n* patients treated with a molecular targeted agent as a part of a clinical study\n\nExclusion Criteria:\n\n* patients with another type of head and neck cancer\n* patients non treated with targeted therapies'}, 'identificationModule': {'nctId': 'NCT02139020', 'briefTitle': 'Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Prospective Collection of Plasma Samples From Patients Treated With Molecular Targeted Therapies for Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'UCL-ONCO 2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment', 'description': 'Patients with squamous cell carcinoma of the head and neck, targeted therapies, plasma samples:\n\n* Group 1 = patients treated with radiation therapy and cetuximab according to Bonner et al \\[11\\]\n* Group 2 = patients treated with cetuximab in combination with chemotherapy according to Vermorken et al. \\[10\\]\n* Group 3 = patients treated with a molecular targeted agent as a part of a clinical study', 'interventionNames': ['Other: Plasma samples']}], 'interventions': [{'name': 'Plasma samples', 'type': 'OTHER', 'description': 'Plasma samples at baseline (and one whole blood sample) and at every radiological evaluations', 'armGroupLabels': ['No treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1340', 'city': 'Ottignies', 'state': 'Brabant Wallon', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Renaud Poncin, MD', 'role': 'CONTACT', 'email': 'Re.PONCIN@clinique-saint-pierre.be'}, {'name': 'Dora Barrientos, Nurse', 'role': 'CONTACT'}, {'name': 'Renaud Poncin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Saint-Pierre', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}, {'zip': '6000', 'city': 'Charleroi', 'state': 'Hainaut', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Christophe Lonchay, MD', 'role': 'CONTACT', 'email': 'Christophe.Lonchay@ghdc.be;'}, {'name': 'Janique Dewelle, Bio MSc', 'role': 'CONTACT'}, {'name': 'Christophe Lonchay, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Grand Hôpital de Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '7100', 'city': 'Haine-Saint-Paul', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Emmanuel Seront, MD, PhD', 'role': 'CONTACT', 'email': 'Emmanuel.Seront@jolimont.be'}, {'name': 'Isabelle Buelens, Study Co', 'role': 'CONTACT'}, {'name': 'Emmanuel Seront, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Jolimont-Lobbes-Nivelles-Tubize', 'geoPoint': {'lat': 50.45544, 'lon': 4.1885}}, {'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Maude Piron, PhD', 'role': 'CONTACT', 'email': 'brieuc.sautois@chuliege.be'}, {'name': 'Brieu Sautois', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5000', 'city': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Stéphanie Henry, MD', 'role': 'CONTACT', 'email': 'Stephanie.HENRY@cmsenamur.be'}, {'name': 'Monique Gilsoul, Study Co', 'role': 'CONTACT'}, {'name': 'Stéphanie Henry, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique et Maternité Sainte-Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}], 'centralContacts': [{'name': 'Jean-Pascal Machiels, MD, PhD', 'role': 'CONTACT', 'email': 'jean-pascal.machiels@uclouvain.be', 'phone': '0032 2 764', 'phoneExt': '5457'}, {'name': 'Séverine Carlier, MD', 'role': 'CONTACT', 'email': 'severine.carlier@uclouvain.be', 'phone': '0032 2 764', 'phoneExt': '47849'}], 'overallOfficials': [{'name': 'Jean-Pascal Machiels, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}