Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06403202
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognostic Performance of a Chemogram in Patients With Bladder Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2024-04-19', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chemogram sensitivity', 'timeFrame': '12 months', 'description': "The relevance of the chemogram to the patient's response to treatment will be assessed by calculating sensitivities, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment."}, {'measure': 'Chemogram specificity', 'timeFrame': '12 months', 'description': "The relevance of the chemogram to the patient's response to treatment will be assessed by calculating specificity, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment."}, {'measure': 'Positive predictive value', 'timeFrame': '12 months', 'description': "The relevance of the chemogram to the patient's response to treatment will be assessed by calculating positive predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment."}, {'measure': 'Negative predictive value', 'timeFrame': '12 months', 'description': "The relevance of the chemogram to the patient's response to treatment will be assessed by calculating negative predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment."}], 'secondaryOutcomes': [{'measure': 'Proteomic analysis', 'timeFrame': '12 months', 'description': 'Proteomic analysis will detect various endogenous compounds: metabolites, lipids, peptides and proteins. Protein profiles (chemo-sensitive cancer, chemo-insensitive cancer, non-cancer) can be identified.\n\nand/or transcriptomic'}, {'measure': 'Transcriptomic analysis', 'timeFrame': '12 months', 'description': 'and/or transcriptomic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary Bladder Neoplasms', 'Chemogram'], 'conditions': ['Urinary Bladder Neoplasms']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate chemogram in patients with intermediate-grade superficial bladder cancer and patients with infiltrating bladder cancer, who are likely to be treated according to the standard procedure. This project is based on the premise that treatments - notably chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize the treatment for each patient, while at the same time proposing an approach that is economically bearable for the healthcare system. For both types of bladder tumor, chemotherapy is used either as an alternative to immunotherapy, or as an adjuvant to surgery. Its use is therefore based on its effectiveness in reducing post-treatment recurrence.', 'detailedDescription': 'The project is based on the premise that treatments - particularly chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize treatment for each patient, while proposing an approach that is economically viable for our healthcare system. The chemogram is inspired by the principle of antibiograms, since it tests, for a given patient and in conjunction with oncologists, different chemotherapeutic or targeted treatment options based on clinical and anatomopathological data. These tests are carried out in vitro in academic research laboratories.\n\nWith this study, its proposed a "proof of concept" for the clinical use of chemograms in patients with superficial or infiltrating bladder cancer. The use of chemograms will have no impact whatsoever on the patient\'s treatment, which will be administered according to standard practice. Nevertheless, this study may help determine whether chemograms can detect tumor sensitivity to certain anti-cancer treatments.\n\nIn the years to come, the aim of this research work is to be able to guide the therapeutic management of patients whose tumours are resistant to the treatment envisaged (tumours with intrinsic resistance to treatment). This will avoid unnecessary treatments for the patient, often with very serious side effects.\n\nFor these two types of bladder tumour, the use of a chemogram to detect the tumour\'s chemosensitivity would make treatment more effective and rapid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with intermediate-grade superficial bladder cancer and invasive bladder cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patient\n* Patient with suspected bladder cancer likely to be treated with chemotherapy\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Insufficient tumor volume\n* Patient under guardianship\n* Pregnant or breast-feeding women\n* Patient opposed to participation in the study'}, 'identificationModule': {'nctId': 'NCT06403202', 'acronym': 'CHEMOGRAM', 'briefTitle': 'Prognostic Performance of a Chemogram in Patients With Bladder Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Prognostic Performance of a Chemogram in Patients With Intermediate-grade Superficial Bladder Cancer and Invasive Bladder Cancer: Proof of Concept.', 'orgStudyIdInfo': {'id': 'RC-P0095'}}, 'contactsLocationsModule': {'locations': [{'zip': '59160', 'city': 'Lomme', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Louis Bonnal', 'role': 'CONTACT', 'email': 'bonnal.jean-louis@ghicl.net'}], 'facility': 'Hôpital St Philibert', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}], 'centralContacts': [{'name': 'Marie-Paule Lebitasy', 'role': 'CONTACT', 'email': 'lebitasy.marie-paule@ghicl.net', 'phone': '033 3 20 22 52 69'}, {'name': 'Berenice MARCHANT', 'role': 'CONTACT', 'email': 'marchant.berenice@ghicl.net', 'phone': '03.20.22.57.51'}], 'overallOfficials': [{'name': 'Jean-Louis Bonnal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GHICL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}