Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
Study NCT ID:
NCT04008095
Status:
RECRUITING
Last Update Posted:
2023-04-07
First Post:
2019-05-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.', 'timeFrame': 'Validated by six months follow up', 'description': 'Investigators will compare\n\n* decision of clinicians without 18F-FDG PET/CT results\n* and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.\n\nGold Standard for the diagnosis of progression will be based on the conclusions of multi-disciplinary staff ruling on the results of composite data, including clinical examination, biology, histopathology, morphological imaging (MRI), functional imaging (PET/CT) and 6-month follow-up.'}, {'measure': 'collection of the two décisions of RCP', 'timeFrame': 'Validated by six months follow up', 'description': 'To make statistical analysis possible, the collection of the two decisions will be chosen from three cases of care envisaged below:\n\n1. Complete therapeutic response\n2. Equivocal response: doubt about the presence of residual disease.\n3. Strong suspicion of residual disease and/or progression Then, we will collect a percentage of patients with rightly changes on management induced by the result of the PET-CT at 18F-FDG.'}], 'secondaryOutcomes': [{'measure': 'Physiological analysis parameter', 'timeFrame': '24 months follow up', 'description': 'Diagnostic performances of PET/CT, Sensibility, Specificity, positive predictive value, negative predictive value'}, {'measure': 'Prognostic factors', 'timeFrame': '24 months follow up', 'description': 'Especially dynamic parameters (SUV max ...) and search for a statistical correlation between this value and PFS and OS.'}, {'measure': 'Physiological analysis, hotspots study', 'timeFrame': '24 months follow up', 'description': 'Hotspots study - Search for a density intersection between the local site residual disease of post-therapeutic 18F-FDG PET/CT and maximum-fixing tumor sites in 18F-FDG PET/CT Baseline.'}, {'measure': 'Physiological analysis, hotspots study', 'timeFrame': '24 months follow up', 'description': 'Hotspots study - Search maximum-fixing tumor sites in 18F-FDG PET/CT Baseline'}, {'measure': 'Physiological analysis, hotspots study', 'timeFrame': '24 months follow up', 'description': 'Assess the dosimetry of an escalation of the dose on these hotspots.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical cancer', 'pet/ct', 'post-therapeutic', 'advanced stage', 'management'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT in the management of uterine cervical cancer. Post therapy 18F-FDG PET/CT is usually requested by a lot of clinicians.\n\nWhereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.\n\nThis prospective multicenter observational study will evaluate the interest of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with cervical cancer at an advanced stage.\n\nMain outcome :\n\nThe therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.\n\nInvestigators will compare :\n\n* decision of clinicians without 18F-FDG PET/CT results\n* and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.', 'detailedDescription': 'With approximately 3000 new cases estimated in France on 2017, the uterine cervical cancer is the twelfth cancer cause in women, responsible for 1000 deaths per year.\n\nManagement of uterine cervical cancer is well defined before treatment, especially for imaging including systematically pelvic MRI and 18F-FDG PET/CT.\n\nA lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT, due to semi quantitative parameters study, like the SUV max and delta SUV between pre and post therapy 18F-FDG PET/CT or qualitatively with the persistence of positive 18F-FDG PET/CT at the end of therapy.\n\nWhereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.\n\nNevertheless, post therapy 18F-FDG PET/CT is still usually requested by a lot of clinicians.\n\nFurthermore, the group of Parisian public hospital (AP-HP) has established a guide for the management of cervical cancer (2016) and recommends to systematically realize a 18F-FDG PET/CT after treatment for advanced cervical cancer.\n\nMain purpose :\n\nEvaluate the role of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with uterine cervical cancer at an advanced stage.\n\nMain outcome :\n\nThe therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.\n\nInvestigators will compare\n\n* decision of clinicians without 18F-FDG PET/CT results\n* and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women recently diagnosed for an advanced cervical cancer (FIGO 2019 IB3 to IVA), and histologically proved.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient old ≥ 18 years\n* Uterine cervical cancer with locally-advanced (FIGO 2019 IB3 to IVA)\n* Histology: squamous cell carcinoma and adenocarcinoma\n* Feasibility of a curative treatment\n* Having formulated a non-opposition\n\nExclusion Criteria:\n\n* Minor patient \\< 18 years\n* Pregnancy or breastfeeding\n* Other type of tumor than squamous cell carcinoma and adenocarcinoma\n* FIGO 2019 \\< IB3 or \\> IVA\n* Non-eligibility for the examination\n* Contraindication to MRI and PET/CT\n* Previous history of cancer\n* Refusal of participation'}, 'identificationModule': {'nctId': 'NCT04008095', 'acronym': 'COLTEP', 'briefTitle': 'Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Evaluation of the Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer at an Advanced Stage. Multicenter Prospective Observational Study', 'orgStudyIdInfo': {'id': '29BRC19.0084'}}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandra LE DUC-PENNEC', 'role': 'CONTACT', 'email': 'alexandra.leduc-pennec@chu-brest.fr', 'phone': '+332 98 22 3119'}], 'facility': 'CHRU de Brest (Hôpital Morvan)', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '76038', 'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Agathe EDET-SANSON', 'role': 'CONTACT', 'email': 'agathe.edet-sanson@chb.unicancer.fr', 'phone': '+33 2 32 08 25 50'}], 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Alexandra LE DUC-PENNEC', 'role': 'CONTACT', 'email': 'alexandra.leduc-pennec@chu-brest.fr', 'phone': '+33 2 98 22 31 19'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending three years maximum following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data accesss agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}