Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-01 @ 8:23 AM
Study NCT ID:
NCT04946266
Status:
UNKNOWN
Last Update Posted:
2022-01-05
First Post:
2021-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney 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': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of MFI2-AS1', 'timeFrame': '36 month', 'description': 'To assess the link between tumor expression of MFI2-AS1 in patients with localized clear cell kidney carcinoma and the occurrence of relapse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'An exploratory analysis of the expression of MFI2-AS1 will be performed at the plasma level with the objective of comparing this expression with tumor tissue. The objective would be to be able to use long non-coding RNA as a biomarker for diagnosis before tissue analysis and for patient follow-up. In addition, correlations will be made between tumor expression of MFI2-AS1 and genetic and immune alterations in tumors in order to better clarify the link between the expression of this long non-coding RNA and the characteristics of the tumor and of the tumor. tumor microenvironment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with localized kidney tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Localized kidney tumors\\> T1a\n* Patient having signed an informed consent\n* Patient affiliated to a health insurance plan\n* Subject having signed a consent form to participate in research and the constitution of a collection and genetic analyzes\n\nExclusion Criteria:\n\n* Metastatic carcinoma from the outset\n* Contraindication to performing a TAP CT with injection of contrast product\n* Inability to provide informed information about the subject (subject in an emergency situation, difficulties in understanding, etc.)\n* Subject under legal protection\n* Subject under tutorship or curatorship\n* Pregnancy\n* Feeding with milk'}, 'identificationModule': {'nctId': 'NCT04946266', 'acronym': 'MFI2-PREDICT', 'briefTitle': 'Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers', 'orgStudyIdInfo': {'id': '7349'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgical intervention', 'type': 'PROCEDURE', 'description': 'Surgical intervention with collection of tissue material'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'TRICARD Thibault', 'role': 'CONTACT', 'email': 'Thibaut.tricard@chru-strasbourg.fr', 'phone': '+33 03.69.55.10.55'}, {'name': 'TRICARD Thibault', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'MALOUF Gabriel', 'role': 'SUB_INVESTIGATOR'}, {'name': 'LANG Hervé', 'role': 'SUB_INVESTIGATOR'}, {'name': 'BERGERAT Sébastien', 'role': 'SUB_INVESTIGATOR'}, {'name': 'STORY Fleur', 'role': 'SUB_INVESTIGATOR'}, {'name': 'MUNIER Pierre', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'TRICARD Thibault', 'role': 'CONTACT', 'email': 'Thibaut.tricard@chru-strasbourg.fr', 'phone': '+ 33 3.69.55.10.55'}, {'name': 'MALOUF Gabriel', 'role': 'CONTACT', 'email': 'Gabriel.malouf@chru-strasbourg.fr', 'phone': '+33 3.88.11.51.41'}], 'overallOfficials': [{'name': 'TRICARD Thibault', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'les Hôpitaux Universitaires de Strasbourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}