Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT04452266
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2020-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between endometrial cancer and predictif factors', 'timeFrame': 'Baseline', 'description': 'Endometrial cancer (yes/no) and explicative variable: Diabetes before endometrial cancer or Lynch syndrome diagnosis; Smoking ; Maximal Weight ; Age at menarche; Parity ; Age at first birth ; Contraceptive use.'}], 'secondaryOutcomes': [{'measure': 'Correlation between endometrial cancer and predictif factors in post menopausal woman', 'timeFrame': 'Baseline', 'description': 'Endometrial cancer (yes/no) and explicative variable: Menopause age; Hormonal menopause treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lynch syndrome', 'endometrial cancer'], 'conditions': ['Lynch Syndrome']}, 'descriptionModule': {'briefSummary': 'Lynch Syndrome increases Endometrial Cancer Occurrence in women due to failure in MisMatch Repair System. Lifetime Cumulative risk of developing endometrial Cancer is approximatively 40% in women with Lynch Syndrome.\n\nEndometrial cancer is the third women cancer in France. Many risk factors are known in general population. Lots of factors are related to over exposure to estrogen.\n\nData about influence of general risk factors in Women with Lynch Syndrome are poor. Recently, a cohort study appears to have shown a significant decrease in the risk of endometrial cancer with multiparity, the use of hormonal contraception and late menopause in Lynch women. The impact of weight and certain metabolic parameters on the occurrence of endometrial cancers remains poorly known to this day.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women included are all carriers of Lynch syndrome, already diagnosed by genetic analysis in the Molecular Biology Laboratory of the CHU de Lille and whose analysis was transmitted during a consultation at the Guy Fontaine Genetics Clinic during the period from 01/01/1998 to 30/11/2019 at the CHU de Lille or in advanced consultations in the regions.The database PROGENY will be use to extract population corresponding to the study', 'genderDescription': 'woman', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lynch Syndrome Diagnosis at University Hospital\n* Alive at study time\n* Age over 30 at endometrial cancer or Lynch Syndrome Diagnosis\n\nCase group :\n\n\\- No cancer before endometrial cancer diagnosis\n\nControl group :\n\n* No endometrial cancer developped\n* Free cancer women at Lynch Syndrome diagnosis\n\nExclusion Criteria:\n\n* Refusing to participate\n* Poor understanding of the French language\n* Other cancer diagnosed before endometrial cancer\n* Hysterectomy before lynch diagnosis for free cancer women'}, 'identificationModule': {'nctId': 'NCT04452266', 'acronym': 'PrediLynch', 'briefTitle': 'Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome: Study Conducted in the Hauts-de-France', 'orgStudyIdInfo': {'id': '2020_07'}, 'secondaryIdInfos': [{'id': '2020-A00843-36', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'case group', 'description': 'Women with Lynch Syndrome and endometrial Cancer matched on age of endometrial cancer diagnosis', 'interventionNames': ['Other: questionnaire assesment']}, {'label': 'control group', 'description': 'Women with Lynch Syndrome, without Cancer at Lynch Syndrome Diagnostic matched on their age at Lynch Diagnostic', 'interventionNames': ['Other: questionnaire assesment']}], 'interventions': [{'name': 'questionnaire assesment', 'type': 'OTHER', 'description': 'Each patient will to answer questions about their medical history.', 'armGroupLabels': ['case group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Jeanne de Flandres', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Solveig MENU-HESPEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}