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The GEOLynch Cohort Study (GEOLynch)

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ClinicalTrials.gov Identifier: NCT03303833
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Collaborators:
Wereld Kanker Onderzoek Fonds
Dutch Cancer Society
Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands
Information provided by (Responsible Party):
Wageningen University

Study Description
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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.

Condition or disease Intervention/treatment
Lynch Syndrome Neoplasms Hereditary Nonpolyposis Colorectal Cancer Colorectal Neoplasms Other: No intervention, observational study.

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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The GEOLynch Cohort Study: Genetic, Environmental and Other Factors That Influence Tumour Risk Among Persons With Lynch Syndrome
Actual Study Start Date : July 1, 2006
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Persons with Lynch syndrome Other: No intervention, observational study.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Buccal swabs and blood samples.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303833


Contacts
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Contact: Fränzel van Duijnhoven, PhD +31 317 485 375 franzel.vanduijnhoven@wur.nl

Locations
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Netherlands
Wageningen University Recruiting
Wageningen, Netherlands
Contact: Fränzel van Duijnhoven, PhD    +31 317 485 375    franzel.vanduijnhoven@wur.nl   
Sponsors and Collaborators
Wageningen University
Wereld Kanker Onderzoek Fonds
Dutch Cancer Society
Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands
Investigators
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Principal Investigator: Ellen Kampman, PhD Wageningen University
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT03303833    
Other Study ID Numbers: CMO 2005-283
2014/1184 ( Other Grant/Funding Number: Wereld Kanker Onderzoek Fonds (WCRF NL) )
2005-3275 / 2007-3842 ( Other Grant/Funding Number: Dutch Cancer Society (KWF) )
CP2013-58 ( Other Grant/Funding Number: Biobanking and BioMolecular resources Research Infrastructure The Netherlands (BBMRI) )
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wageningen University:
Lifestyle
Nutrition
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Syndrome
Disease
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases