Molecular Screening for Lynch Syndrome in Denmark

• Sponsor: Vejle Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01845753
• Collaborator: (none)
• Enrollment: 5,000
• Locations: 11
• Actual Duration (Months): 87
• Patients Per Site: 454.5
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Lynch Syndrome; HNPCC	Other: Observation

Study Design

• Study Type: Observational
• Actual Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Molecular Screening for Lynch Syndrome in Denmark
• Actual Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
All colorectal cancer patients	Other: Observation; Observation

Outcome Measures

Primary Outcome Measures

1. Rate of Lynch Syndrome in a population of primary colorectal cancer [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histological diagnosis of colorectal adenocarcinoma

• Diagnosed at one of the departments of pathology in Denmark

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pathology	Aalborg		Denmark
2	Department of Clinical Genetics	Aarhus		Denmark
3	Department of Pathology	Aarhus		Denmark
4	Department of Pathology	Esbjerg		Denmark
5	Department of Pathology	Hjørring		Denmark
6	Department of Clinical Genetics	Odense		Denmark
7	Department of Pathology	Odense		Denmark
8	Department of Pathology	Sønderborg		Denmark
9	Vejle Hospital	Vejle		Denmark	7100
10	Department of Clinical Genetics	Vejle		Denmark
11	Department of Pathology	Vejle		Denmark

Sponsors and Collaborators

• Vejle Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vejle Hospital
• ClinicalTrials.gov Identifier: NCT01845753
• Other Study ID Numbers: MS-LS-DK-02
• First Posted: May 3, 2013
• Last Update Posted: Jan 23, 2020
• Last Verified: Jan 1, 2020

• Additional relevant MeSH terms: Colorectal Neoplasms, Hereditary Nonpolyposis; Syndrome

Study Results

No Results Posted as of Jan 23, 2020