Molecular Screening for Lynch Syndrome in Southern Denmark

Colorectal Cancer Clinical Trial

Official title:

Molecular Screening for Lynch Syndrome in Southern Denmark

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216930
• Other study ID #: MS-LS-DK-01
• Secondary ID: 10-5156
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: September 11, 2015
• Start date: October 2010
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Board of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: September 2015
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Histological diagnosis of colorectal adenocarcinoma

• Diagnosed at one of the five departments of pathology in the region

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms, Hereditary Nonpolyposis
• HNPCC
• Lynch Syndrome
• Syndrome

Intervention

Other:
• Observation
Observation

Locations

Country	Name	City	State
Denmark	Department of Pathology	Esbjerg
Denmark	Department of Clinical Genetics	Odense
Denmark	Department of Pathology	Odense
Denmark	Department of Pathology	Sønderborg
Denmark	Department of Pahology	Svendborg
Denmark	Department of Clinical Genetics	Vejle
Denmark	Department of Pathology	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark,