Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-02 @ 2:02 PM
Study NCT ID:
NCT02849158
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2016-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Metastatic spread evaluation', 'timeFrame': '3 years', 'description': 'On a mouse model of orthotopic rectal cancer, assessment of the potential and metastatic tumor growth'}, {'measure': 'Outcomes 1 to 3 correlation with histological response after RT-CT', 'timeFrame': '3 years', 'description': 'Histological response after RT-CT assessed according to the tumor regression grading - Dworak 1997'}, {'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'Disease-free Survival assessment'}], 'primaryOutcomes': [{'measure': 'Proteomic level evaluation in intra-tumor fibroblast', 'timeFrame': '3 years', 'description': 'Proteomic level is assessed before and after radiochemotherapy using SILAC technic (Stable Isotope Labeling by Amino acids in Cell culture)'}], 'secondaryOutcomes': [{'measure': 'Study of fibroblast impact on colorectal tumor cells (in vitro)', 'timeFrame': '3 years', 'description': 'In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectoscopy', 'Proctectomy', 'Fibroblasts'], 'conditions': ['Rectum Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.', 'detailedDescription': 'Patients included in the trial will have new biopsy performed before starting the Radiation Therapy and Chemotherapy (RT-CT). These biopsies will study the activity of fibroblasts in the tumor and away in the healthy rectal tissue. Within 8 to 10 weeks after the end of RT-CT, patients will have cancer surgery by proctectomy (with complete removal of the meso-rectum). On the resection specimen, new samples will be taken at the level of the tumor and away from the rectum.This study is single center interventional exploratory .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Middle rectum adenocarcinoma Tumor(T)x Node (N)+ or T3 /T4 N0 or N+\n2. Classification done on pelvic Magnetic Resonance Imaging (MRI) and rectal ultrasonography\n3. Age ≥ 18\n4. No contraindication to treatment with capecitabine\n5. Able to receive radiotherapy 50 Grays in 5 weeks\n6. No contraindication for surgery after chemoradiotherapy which will be 8 to 10 weeks after completion of chemoradiotherapy\n7. Patient or legal representative provided with information and signature of informed consent\n\nExclusion Criteria:\n\n1. High rectum adenocarcinoma\n2. Contraindication to rectal biopsy: including anti-coagulants or anti-platelet agents (vitamin K antagonists, clopidogrel, aspirin \\> 160 grams) that cannot be interrupted\n3. Pregnant woman or breastfeeding\n4. Persons deprived of their liberty, or under guardianship\n5. Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons.\n6. Patient already included in another therapeutic trial with an experimental medication during the realization of protocol biopsies and surgery\n7. Patient not covered by health insurance"}, 'identificationModule': {'nctId': 'NCT02849158', 'acronym': 'FibroRect', 'briefTitle': 'Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study', 'orgStudyIdInfo': {'id': 'IC 2015-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biopsy', 'description': 'Patients will have new biopsy before starting RT-CT and samples will be taken on rectum surgery at the level of the tumor and away from the rectum.', 'interventionNames': ['Other: Biopsy']}], 'interventions': [{'name': 'Biopsy', 'type': 'OTHER', 'description': 'Rectoscopy with biopsy', 'armGroupLabels': ['Biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'INSTITUT CURIE - Site Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75248', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92210', 'city': 'Saint-Cloud', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Institut Curie - Hôpital René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}], 'overallOfficials': [{'name': 'Pascale MARIANI, LDD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Curie'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.', 'ipdSharing': 'YES', 'description': 'Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.', 'accessCriteria': 'Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}