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The GEOLynch Cohort Study

NCT ID: NCT03303833

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-01

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Lynch Syndrome Neoplasms Hereditary Nonpolyposis Colorectal Cancer Colorectal Neoplasms

Keywords

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Lifestyle Nutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Persons with Lynch syndrome

No intervention, observational study.

Intervention Type OTHER

Interventions

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No intervention, observational study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wereld Kanker Onderzoek Fonds

OTHER

Sponsor Role collaborator

Dutch Cancer Society

OTHER

Sponsor Role collaborator

Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands

UNKNOWN

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen Kampman, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Wageningen University

Wageningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Fränzel van Duijnhoven, PhD

Role: CONTACT

Phone: +31 317 485 375

Email: [email protected]

Facility Contacts

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Fränzel van Duijnhoven, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23657759 (View on PubMed)

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.

Reference Type RESULT
PMID: 24916333 (View on PubMed)

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.

Reference Type RESULT
PMID: 20733131 (View on PubMed)

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.

Reference Type RESULT
PMID: 22062356 (View on PubMed)

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.

Reference Type RESULT
PMID: 23254892 (View on PubMed)

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.

Reference Type RESULT
PMID: 23825568 (View on PubMed)

Related Links

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http://www.geolynch-studie.nl/geolynchstudy_eng

GEOLynch website

Other Identifiers

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2014/1184

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2005-3275 / 2007-3842

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CP2013-58

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CMO 2005-283

Identifier Type: -

Identifier Source: org_study_id