The GEOLynch Cohort Study (GEOLynch)

October 5, 2017 updated by: Wageningen University

The GEOLynch Cohort Study: Genetic, Environmental and Other Factors That Influence Tumour Risk Among Persons With Lynch Syndrome

The GEOLynch cohort study has been established to investigate the influence of genetic, environmental and other factors on tumour risk in persons with Lynch syndrome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The GEOLynch cohort study includes persons with Lynch syndrome (LS) only. Persons with LS carry an inherited mutation in one of the DNA mismatch repair genes MLH1, MSH2, MSH6 or PMS2 which increases their risk of several types of cancer, especially colorectal and endometrial cancer. Additionally, mutations in the EPCAM gene that result in epigenetic silencing of the MSH2 gene cause LS. Since 2006, persons with LS are invited to participate in the GEOLynch cohort study via the Netherlands Foundation for the Detection of Hereditary Tumours, the Radboud University Medical Center Nijmegen or the University Medical Centre Groningen. Moreover, persons with LS can participate in the study after contacting the researcher themselves. Participants are asked to complete a food frequency questionnaire and questionnaires about dietary supplement use, physical activity, weight, height and medication use. A buccal swab was asked of every participant recruited between 2006 and 2008. From 2012 on, newly recruited participants are asked to donate a blood sample instead of a buccal swab. Furthermore, participants who had been recruited between 2006 and 2008 were asked to complete the questionnaires again and to donate a blood sample too. Hence, follow-up measurements are available for a subset of participants. DNA has been subtracted from the buccal swabs to genotype SNPs of the IGF gene axis and polymorphisms of MTHFR C377T. Blood samples are biobanked to facilitate future analyses of biomarkers, nutrients, DNA etc. Clinical characteristics regarding performed colonoscopies and tumour diagnoses of all participants is gathered from medical records and a linkage to the nationwide network and registry of histo- and cytopathology in the Netherlands (PALGA Foundation ). Hazard ratios will be calculated to investigate the influence of genetic, environmental and other factor on tumour risk. Repeated measures analyses will be used if follow-up measurements are taken into account.

Study Type

Observational

Enrollment (Anticipated)

1000

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

  • Netherlands
      • Wageningen, Netherlands
        • Recruiting
        • Wageningen University

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Study Population

Men and women aged 18 to 80 years with Lynch syndrome who do or do not have a (previous) cancer diagnosis.

Description

Inclusion Criteria:

  • Persons with a known mutation in a gene that causes Lynch syndrome, i.e. with an inherited monoallelic pathogenic germline mutation in either the MLH1, MSH2, MSH6, PMS2 or EPCAM gene.
  • Aged between 18 and 80 years at inclusion.

Exclusion Criteria:

  • Additional carrier of another hereditary colon cancer predisposition syndrome (e.g. FAP)
  • (Chronic) Inflammatory bowel disease
  • Non-Dutch speaking
  • Dementia or another mental condition that makes it impossible to fill out questionnaires
  • Terminally ill persons

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Persons with Lynch syndrome
Other: No intervention, observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colorectal tumour diagnoses
Time Frame: Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.
All diagnosed colorectal adenomas and carcinomas described in paticipants' medical reports and/or pathology reports.
Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.
Endometrial cancer diagnoses
Time Frame: Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.
All diagnosed endometrial cancers described in participants' medical reports and/or pathology reports.
Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.
Overall cancer diagnoses
Time Frame: Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.
All diagnosed cancer types described in participants' medical reports and/or pathology reports.
Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.

Collaborators and Investigators

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

Sponsor

Wageningen University

Collaborators

Dutch Cancer Society
Wereld Kanker Onderzoek Fonds
Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 1, 2006

Primary Completion (ANTICIPATED)

December 1, 2030

Study Completion (ANTICIPATED)

December 1, 2030

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (ACTUAL)

October 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMO 2005-283
  • 2014/1184 (OTHER_GRANT: Wereld Kanker Onderzoek Fonds (WCRF NL))
  • 2005-3275 / 2007-3842 (OTHER_GRANT: Dutch Cancer Society (KWF))
  • CP2013-58 (OTHER_GRANT: Biobanking and BioMolecular resources Research Infrastructure The Netherlands (BBMRI))

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.

Clinical Trials on Neoplasms

Clinical Trials on No intervention, observational study.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe