Lynch SyndromeGEOLynchNCT03303833
The GEOLynch Cohort Study
An observational study of Lynch Syndrome and Neoplasms, run by Wageningen University at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lynch Syndrome, Neoplasms, Hereditary Nonpolyposis Colorectal Cancer
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2006to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women aged 18 to 80 years with Lynch syndrome who do or do not have a (previous) cancer diagnosis.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University
Wageningen
Fränzel van Duijnhoven, PhD, +31 317 485 375, franzel.vanduijnhoven@wur.nl
About this study
Official title: The GEOLynch Cohort Study: Genetic, Environmental and Other Factors That Influence Tumour Risk Among Persons With Lynch Syndrome
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.
- Conditions
- Lynch Syndrome, Neoplasms, Hereditary Nonpolyposis Colorectal Cancer, Colorectal Neoplasms
- Being tested
- No intervention, observational study.
- Keywords
- Lifestyle, Nutrition
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational study.Other
| Study group | Role | What they receive |
|---|---|---|
| Persons with Lynch syndrome | Not described Receives: Other: No intervention, observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal tumour diagnoses
All diagnosed colorectal adenomas and carcinomas described in paticipants' medical reports and/or pathology reports.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Jul 2006
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Wereld Kanker Onderzoek Fonds, Dutch Cancer Society, Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands
- Responsible party
- Sponsor
- Investigators
- Ellen Kampman, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303833
- Sponsor's protocol ID
- CMO 2005-283
- Other IDs
- 2014/1184, 2005-3275 / 2007-3842, CP2013-58
- Acronym
- GEOLynch
- Status last verified
- Oct 2017
- First submitted
- 14 Sep 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 23657759Jung 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 24916333Botma 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 20733131Winkels 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 22062356Botma 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 23254892Heine-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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GEOLynch Cohort Study: Genetic, Environmental and Other Factors That Influence Tumour Risk Among Persons With Lynch Syndrome
- ClinicalTrials.gov ID
- NCT03303833
- Acronym / sponsor ID
- GEOLynch / CMO 2005-283
- Conditions
- Lynch Syndrome, Neoplasms, Hereditary Nonpolyposis Colorectal Cancer, Colorectal Neoplasms
- Keywords
- Lifestyle, Nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Wereld Kanker Onderzoek Fonds, Dutch Cancer Society, Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands
- Study start
- 1 Jul 2006 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with Lynch syndrome | – | Other: No intervention, observational study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women aged 18 to 80 years with Lynch syndrome who do or do not have a (previous) cancer diagnosis.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observational study. | Other | Persons with Lynch syndrome |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 23657759van 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.
- Results publication: PubMed 24916333Jung 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.
- Results publication: PubMed 20733131Botma 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.
- Results publication: PubMed 22062356Winkels 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.
- Results publication: PubMed 23254892Botma 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.
- Results publication: PubMed 23825568Heine-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.
- GEOLynch websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen Kampman, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lynch Syndrome and Neoplasms, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fränzel van Duijnhoven, PhD (+31 317 485 375, franzel.vanduijnhoven@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03303833, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.