Molecular Screening for Lynch Syndrome in Denmark

January 22, 2020 updated by: Vejle Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Department of Pathology
      • Aarhus, Denmark
        • Department of Clinical Genetics
      • Aarhus, Denmark
        • Department of Pathology
      • Esbjerg, Denmark
        • Department of Pathology
      • Hjørring, Denmark
        • Department of Pathology
      • Odense, Denmark
        • Department of Clinical Genetics
      • Odense, Denmark
        • Department of Pathology
      • Sønderborg, Denmark
        • Department of Pathology
      • Vejle, Denmark, 7100
        • Vejle Hospital
      • Vejle, Denmark
        • Department of Clinical Genetics
      • Vejle, Denmark
        • Department of Pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All colorectal cancer patients in Denmark

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All colorectal cancer patients
Other: Observation
Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Lynch Syndrome in a population of primary colorectal cancer
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2012

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (ESTIMATE)

May 3, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-LS-DK-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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