Molecular Screening for Lynch Syndrome in Southern Denmark

A clinically applicably strategy for molecular screening for Lynch Syndrome has been implemented in the Region of Southern 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): 2000

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark
    • Department of Pathology
  • Odense, Denmark
    • Department of Clinical Genetics
  • Odense, Denmark
    • Department of Pathology
  • Svendborg, Denmark
    • Department of Pahology
  • Sønderborg, Denmark
    • Department of Pathology
  • Vejle, Denmark
    • Department of Clinical Genetics
  • Vejle, Denmark
    • Department of Pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All colorectal cancer patients in the geographical region of southern Denmark

Description

Inclusion Criteria:

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

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

Collaborators and Investigators

• Sponsor: Vejle Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: October 6, 2010
• First Posted (Estimate): October 7, 2010

Study Record Updates

• Last Update Posted (Estimate): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: September 1, 2015

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-01; 10-5156 (Other Grant/Funding Number: Region of Southern Denmark)