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NCT04452266 Clinical Trial

Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome

Lynch Syndrome Clinical Trial

— PrediLynch  

Official title:
Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome: Study Conducted in the Hauts-de-France

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04452266
Other study ID # 2020_07
Secondary ID 2020-A00843-36
Status Completed
Phase
First received
Last updated
Start date August 14, 2020
Est. completion date October 20, 2020

Study information
Verified date March 2021
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. Endometrial 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. Data 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date October 20, 2020
Est. primary completion date October 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years and older
Eligibility Inclusion Criteria: - Lynch Syndrome Diagnosis at University Hospital - Alive at study time - Age over 30 at endometrial cancer or Lynch Syndrome Diagnosis Case group : - No cancer before endometrial cancer diagnosis Control group : - No endometrial cancer developped - Free cancer women at Lynch Syndrome diagnosis Exclusion Criteria: - Refusing to participate - Poor understanding of the French language - Other cancer diagnosed before endometrial cancer - Hysterectomy before lynch diagnosis for free cancer women

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• questionnaire assesment
Each patient will to answer questions about their medical history.

Locations
Country Name City State
France Hôpital Jeanne de Flandres Lille

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between endometrial cancer and predictif factors 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. Baseline
Secondary Correlation between endometrial cancer and predictif factors in post menopausal woman Endometrial cancer (yes/no) and explicative variable: Menopause age; Hormonal menopause treatment Baseline
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