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

March 8, 2021 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Hopital Jeanne de Flandres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case group
Women with Lynch Syndrome and endometrial Cancer matched on age of endometrial cancer diagnosis
Other: questionnaire assesment
Each patient will to answer questions about their medical history.
control group
Women with Lynch Syndrome, without Cancer at Lynch Syndrome Diagnostic matched on their age at Lynch Diagnostic
Other: questionnaire assesment
Each patient will to answer questions about their medical history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between endometrial cancer and predictif factors
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between endometrial cancer and predictif factors in post menopausal woman
Time Frame: Baseline
Endometrial cancer (yes/no) and explicative variable: Menopause age; Hormonal menopause treatment
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Solveig MENU-HESPEL, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2020

Primary Completion (Actual)

October 20, 2020

Study Completion (Actual)

October 20, 2020

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_07
  • 2020-A00843-36 (Other Identifier: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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