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

NCT04452266 | Completed

• 2 other identifiers: 2020_072020-A00843-36
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lynch Syndrome

Keywords

lynch syndrome; endometrial cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between endometrial cancer and predictif factors in post menopausal woman

  Baseline

Study Arms (2)

case group

Women with Lynch Syndrome and endometrial Cancer matched on age of endometrial cancer diagnosis

Other: questionnaire assesment

control group

Women with Lynch Syndrome, without Cancer at Lynch Syndrome Diagnostic matched on their age at Lynch Diagnostic

Other: questionnaire assesment

Interventions

questionnaire assesment OTHER

Each patient will to answer questions about their medical history.

case group; control group

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Refusing to participate
• Poor understanding of the French language
• Other cancer diagnosed before endometrial cancer
• Hysterectomy before lynch diagnosis for free cancer women

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Jeanne de Flandres

Lille, 59000, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Solveig MENU-HESPEL, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: August 14, 2020
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)