Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-06 @ 10:15 PM
Study NCT ID:
NCT02842294
Status:
UNKNOWN
Last Update Posted:
2016-07-22
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study to Assess Impact of Chemotherapy Plus Bevacizumab on Health Related Quality of Life in First Line Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-07-21', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to health related quality of life score deterioration (targeted dimensions of EORTC QLQC30 : global health, fatigue, emotional functioning)', 'timeFrame': '1 year', 'description': 'The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.'}], 'secondaryOutcomes': [{'measure': 'time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29)', 'timeFrame': '1 year'}, {'measure': 'INT PATSAT32', 'timeFrame': '1 year', 'description': "The EORTC IN-PATSAT32 is a 32-item satisfaction with care questionnaire to measure patients' appraisal of hospital doctors and nurses, as well as aspects of care organisation and services. It addresses technical competence, information provision, interpersonal skills, availability, waiting time, access, comfort and overall care perception"}, {'measure': 'quality-adjusted life years (QALYs) using EQ5D', 'timeFrame': '1 year'}, {'measure': 'Overall survival', 'timeFrame': '2 years'}, {'measure': 'Progression Free Survival', 'timeFrame': '1 year'}, {'measure': 'treatment preference', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bevacizumab', 'health related quality of life'], 'conditions': ['Metastatic Colorectal Cancer', 'Quality of Life']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.umqvc.org/en/index.html', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this french multicenter national study is to assess and compare time to quality of life score deterioration (targeted dimensions : global health, fatigue and emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated with bevacizumab in metastatic colorectal patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'metastatic colorectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\> 18years\n* metastatic colorectal cancer (non resectable)\n* 1st chemotherapy including bevacizuman\n\nExclusion Criteria:\n\n* treatment contre-indication'}, 'identificationModule': {'nctId': 'NCT02842294', 'acronym': 'COBEQOL', 'briefTitle': 'Cohort Study to Assess Impact of Chemotherapy Plus Bevacizumab on Health Related Quality of Life in First Line Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': "Etude de Cohorte évaluant l'Impact de l'Association chimiothérapie et Bevacizumab en 1ère Ligne du Cancer Colorectal métastatique Sur la qualité de Vie Relative Des Patients. Etude COBEQOL", 'orgStudyIdInfo': {'id': 'P/2012/151'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'irinotecan based chemotherapy', 'description': 'patients having a 1st line doublet chemotherapy including irinotecan', 'interventionNames': ['Drug: Bevacizumab']}, {'label': 'oxaliplatin based chemotherapy', 'description': 'patients having a 1st line doublet chemotherapy including oxaliplatin', 'interventionNames': ['Drug: Bevacizumab']}, {'label': 'triplet chemotherapy', 'description': 'patient having a 1st line triplet chemotherapy including oxaliplatin / irinotecan this cohort was added while primary objective was to compare doublet chemotherapy', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'armGroupLabels': ['irinotecan based chemotherapy', 'oxaliplatin based chemotherapy', 'triplet chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'state': 'Franche Comté', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ikram es saad, msc', 'role': 'CONTACT', 'email': 'iessaad@chu-besancon.fr', 'phone': '0370632181', 'phoneExt': '0033'}], 'facility': 'CHRU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Marion Jacquin, Msc', 'role': 'CONTACT', 'email': 'fbonnetain@chu-besancon.fr', 'phone': '0033370632171'}, {'name': 'Ikram El SaaD, Msc', 'role': 'CONTACT', 'email': 'iessaad@chu-besancon.fr', 'phone': '0033370632181'}], 'overallOfficials': [{'name': 'Franck Bonnetain, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Besancon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}