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The GEOLynch Cohort Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03303833
Acronym
GEOLynch
Enrollment
1000
Registered
2017-10-06
Start date
2006-07-01
Completion date
2030-12-31
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis Colorectal Cancer, Lynch Syndrome, Neoplasms

Keywords

Lifestyle, Nutrition

Brief summary

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.

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.

Interventions

OTHERNo intervention, observational study.

Sponsors

Wereld Kanker Onderzoek Fonds
CollaboratorOTHER
Dutch Cancer Society
CollaboratorOTHER
Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands
CollaboratorUNKNOWN
Wageningen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Colorectal tumour diagnosesDiagnoses 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.
Endometrial cancer diagnosesDiagnoses 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.
Overall cancer diagnosesDiagnoses 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.

Countries

Netherlands

Contacts

Primary ContactFränzel van Duijnhoven, PhD
franzel.vanduijnhoven@wur.nl+31 317 485 375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026