Molecular Screening for Lynch Syndrome in Denmark

Colorectal Cancer Clinical Trial

Official title:

Molecular Screening for Lynch Syndrome in Denmark

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845753
• Other study ID #: MS-LS-DK-02
• Status: Completed
• Start date: October 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: December 31, 2019
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Histological diagnosis of colorectal adenocarcinoma

• Diagnosed at one of the departments of pathology in Denmark

Exclusion Criteria:

• None

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

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Lynch Syndrome in a population of primary colorectal cancer		1 year