Lynch SyndromePrediLynchNCT04452266
Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome
An observational study of Lynch Syndrome, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- questionnaire assesment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 14 Aug 2020to 20 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Refusing to participate
- Poor understanding of the French language
- Other cancer diagnosed before endometrial cancer
- Hysterectomy before lynch diagnosis for free cancer women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lynch Syndrome
- Being tested
- questionnaire assesment
- Keywords
- lynch syndrome, endometrial cancer
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire assesmentOther
Each patient will to answer questions about their medical history.
| Study group | Role | What they receive |
|---|---|---|
| case group | Women with Lynch Syndrome and endometrial Cancer matched on age of endometrial cancer diagnosis Receives: Other: questionnaire assesment | |
| control group | Women with Lynch Syndrome, without Cancer at Lynch Syndrome Diagnostic matched on their age at Lynch Diagnostic Receives: Other: questionnaire assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Correlation between endometrial cancer and predictif factors in post menopausal woman
Endometrial cancer (yes/no) and explicative variable: Menopause age; Hormonal menopause treatment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start14 Aug 2020
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Solveig MENU-HESPEL, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452266
- Sponsor's protocol ID
- 2020_07
- Other IDs
- 2020-A00843-36
- Acronym
- PrediLynch
- Status last verified
- Mar 2021
- First submitted
- 25 Jun 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome: Study Conducted in the Hauts-de-France
- ClinicalTrials.gov ID
- NCT04452266
- Acronym / sponsor ID
- PrediLynch / 2020_07
- Conditions
- Lynch Syndrome
- Keywords
- lynch syndrome, endometrial cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Other: questionnaire assesmentWomen with Lynch Syndrome and endometrial Cancer matched on age of endometrial cancer diagnosis |
| control group | – | Other: questionnaire assesmentWomen with Lynch Syndrome, without Cancer at Lynch Syndrome Diagnostic matched on their age at Lynch Diagnostic |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- Lynch Syndrome Diagnosis at University Hospital
- Alive at study time
- Age over 30 at endometrial cancer or Lynch Syndrome Diagnosis
- No cancer before endometrial cancer diagnosis
- No endometrial cancer developped
Key exclusion criteria (4 listed)
- Refusing to participate
- Poor understanding of the French language
- Other cancer diagnosed before endometrial cancer
- Hysterectomy before lynch diagnosis for free cancer women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire assesmentEach patient will to answer questions about their medical history. | Other | case group, control group |
Primary outcome
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.
1 secondary outcome
Correlation between endometrial cancer and predictif factors in post menopausal woman
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Lynch Syndrome
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FITting Non-invasive Tests in Lynch Syndrome Surveillance
Colorectal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
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RecruitingObservational study
Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations
Prostate Cancer
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solveig MENU-HESPEL, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lynch Syndrome, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between endometrial cancer and predictif factors (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.