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RecruitingNCT03303833GEOLynchUpdated Oct 6, 2017

The GEOLynch Cohort Study

An observational study in Lynch Syndrome, Neoplasms and Hereditary Nonpolyposis Colorectal Cancer, sponsored by Wageningen University. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-06.

Sponsored by Wageningen University · Observational

From the registry’s dates

  • Started Jul 2006; still recruiting 20 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Lynch Syndrome
  • Neoplasms
  • Hereditary Nonpolyposis Colorectal Cancer
  • Colorectal Neoplasms

Keywords

  • Lifestyle
  • Nutrition
03

In context

Colorectal Neoplasms, Hereditary Nonpolyposis

141 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 60 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 400 across 60 observational studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.

Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →

Lead sponsor

Wageningen University is the lead sponsor of 153 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Persons with Lynch syndrome

    Other: No intervention, observational study.

Interventions

  • OtherNo intervention, observational study.
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What researchers measure

Primary outcomes

  1. Colorectal tumour diagnoses

    All diagnosed colorectal adenomas and carcinomas described in paticipants' medical reports and/or pathology reports.

    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.

  2. Endometrial cancer diagnoses

    All diagnosed endometrial cancers described in participants' medical reports and/or pathology reports.

    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.

  3. Overall cancer diagnoses

    All diagnosed cancer types described in participants' medical reports and/or pathology reports.

    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.

07

Study locations

1 of 1 sites recruiting
  • Wageningen University
    Wageningen, Netherlands
    Recruiting
08

References and documents

Publications

  • van Duijnhoven FJ, Botma A, Winkels R, Nagengast FM, Vasen HF, Kampman E. Do lifestyle factors influence colorectal cancer risk in Lynch syndrome? Fam Cancer. 2013 Jun;12(2):285-93. doi: 10.1007/s10689-013-9645-8. PubMed 23657759 ↗
  • Jung AY, van Duijnhoven FJ, Nagengast FM, Botma A, Heine-Broring RC, Kleibeuker JH, Vasen HF, Harryvan JL, Winkels RM, Kampman E. Dietary B vitamin and methionine intake and MTHFR C677T genotype on risk of colorectal tumors in Lynch syndrome: the GEOLynch cohort study. Cancer Causes Control. 2014 Sep;25(9):1119-29. doi: 10.1007/s10552-014-0412-4. Epub 2014 Jun 12. PubMed 24916333 ↗
  • Botma A, Nagengast FM, Braem MG, Hendriks JC, Kleibeuker JH, Vasen HF, Kampman E. Body mass index increases risk of colorectal adenomas in men with Lynch syndrome: the GEOLynch cohort study. J Clin Oncol. 2010 Oct 1;28(28):4346-53. doi: 10.1200/JCO.2010.28.0453. Epub 2010 Aug 23. PubMed 20733131 ↗
  • Winkels RM, Botma A, Van Duijnhoven FJ, Nagengast FM, Kleibeuker JH, Vasen HF, Kampman E. Smoking increases the risk for colorectal adenomas in patients with Lynch syndrome. Gastroenterology. 2012 Feb;142(2):241-7. doi: 10.1053/j.gastro.2011.10.033. Epub 2011 Nov 4. PubMed 22062356 ↗
  • Botma A, Vasen HF, van Duijnhoven FJ, Kleibeuker JH, Nagengast FM, Kampman E. Dietary patterns and colorectal adenomas in Lynch syndrome: the GEOLynch cohort study. Cancer. 2013 Feb 1;119(3):512-21. doi: 10.1002/cncr.27726. Epub 2012 Dec 17. PubMed 23254892 ↗
  • Heine-Broring RC, Winkels RM, Botma A, van Duijnhoven FJ, Jung AY, Kleibeuker JH, Nagengast FM, Vasen HF, Kampman E. Dietary Supplement Use and Colorectal Adenoma Risk in Individuals with Lynch Syndrome: The GEOLynch Cohort Study. PLoS One. 2013 Jun 18;8(6):e66819. doi: 10.1371/journal.pone.0066819. Print 2013. PubMed 23825568 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03303833
Collaborators
Wereld Kanker Onderzoek Fonds, Dutch Cancer Society, Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands
Responsible party
Sponsor
First posted
Oct 6, 2017
Start date
Jul 1, 2006
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 6, 2017

Study contacts

Fränzel van Duijnhoven, PhD
Contact
franzel.vanduijnhoven@wur.nl
+31 317 485 375
Ellen Kampman, PhD
principal investigator · Wageningen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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