Molecular Screening for Lynch Syndrome in Denmark

Completed

• Conditions: Lynch Syndrome; HNPCC; Colorectal Cancer
• Interventions: Other: Observation

• Registration Number: NCT01845753
• Lead Sponsor: Vejle Hospital

Brief Summary

A clinically applicably strategy for molecular screening for Lynch Syndrome is being implemented in Denmark.

Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. These patients are offered genetic risk assessment and counselling.

The study hypothesis is that molecular screening will identify more patients with Lynch Syndrome than the family history alone.

Prospective data collection is performed using established clinical databases.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-03
• Primary Completion: 2015-02
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Histological diagnosis of colorectal adenocarcinoma
• Diagnosed at one of the departments of pathology in Denmark

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All colorectal cancer patients	Observation	-

Primary Outcome Measures

Name	Time	Method
Rate of Lynch Syndrome in a population of primary colorectal cancer	1 year

Trial Locations

Locations (3)

Department of Pathology; 🇩🇰 Vejle, Denmark

Department of Clinical Genetics; 🇩🇰 Vejle, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark