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Chromoendoscopy in Lynch syndrome patients

Chromoendoscopy in Lynch syndrome patients - ChromoLynch

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32242
Enrollment
300
Registered
2008-12-02
Start date
2008-04-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HNPCC Lynch syndrome

Interventions

Patients will be randomised between conventional colonoscopy and chromoendoscopy at baseline, followed by chromoendoscopy in all patients at two year follow-up.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Proven or obligate (carrier state based on the position in the pedigree) mutation carriers, with a known mutation in the hMLH1, hMSH2 or hMSH6 gene, - who have their entire proximal colon in situ and - are aged between 20 and 70 years and - if written informed consent is provided.

Exclusion criteria

Exclusion criteria: Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Design outcomes

Primary

MeasureTime frame
The primary endpoints of the study are the number of adenomas, advanced adenomas, carcinomas at baseline and the number of the number of adenomas, advanced adenomas, carcinomas and the number of patients requiring colectomy at 2-year follow-up.

Secondary

MeasureTime frame
The secundary endpoints of the study are the number of complications from colonoscopy at baseline and at 2-year follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)