Molecular Screening for Lynch Syndrome in Denmark

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: Colorectal Cancer; Lynch Syndrome; HNPCC
• Intervention / Treatment: Other: Observation

• Study Type: Observational
• Enrollment (Actual): 5000

Contacts and Locations

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

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

How is the study designed?

Number of groups / cohorts

1

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	1 year

Collaborators and Investigators

• Sponsor: Vejle Hospital

Study record dates

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: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Neoplasms; Neoplasms by Site; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: MS-LS-DK-02