NCT03303833

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jul 2006Dec 2030

Study Start

First participant enrolled

July 1, 2006

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

24.4 years

First QC Date

September 14, 2017

Last Update Submit

October 5, 2017

Conditions

Keywords

LifestyleNutrition

Outcome Measures

Primary Outcomes (3)

  • Colorectal tumour diagnoses

    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

    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

    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.

Study Arms (1)

Persons with Lynch syndrome

Other: No intervention, observational study.

Interventions

Persons with Lynch syndrome

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Netherlands

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23657759BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swabs and blood samples.

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary NonpolyposisNeoplasmsColorectal Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Ellen Kampman, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fränzel van Duijnhoven, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

October 6, 2017

Study Start

July 1, 2006

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations