Molecular Screening for Lynch Syndrome in Southern Denmark

This study is currently recruiting participants.

Verified May 2012 by Vejle Hospital

First Received on October 6, 2010. Last Updated on May 8, 2012 History of Changes

Sponsor:	Vejle Hospital
Information provided by (Responsible Party):	Vejle Hospital
ClinicalTrials.gov Identifier:	NCT01216930

Purpose

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.

Condition	Intervention
Colorectal Cancer Lynch Syndrome HNPCC	Other: Observation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Molecular Screening for Lynch Syndrome in Southern Denmark

Resource links provided by NLM:

Genetics Home Reference related topics: Lynch syndrome Help Me Understand Genetics

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Vejle Hospital:

Estimated Enrollment:	1700
Study Start Date:	October 2010
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
All colorectal cancer patients	Other: Observation Observation

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All colorectal cancer patients in the geographical region of southern Denmark

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216930

Contacts

Contact: Lars Henrik Jensen, MD PhD

+4579406802

lars.henrik.jensen@slb.regionsyddanmark.dk

Locations

Denmark
Department of Pathology	Recruiting
Esbjerg, Denmark
Contact: Solveig Busch
Department of Pathology	Recruiting
Odense, Denmark
Contact: Tina Plato
Department of Clinical Genetics	Recruiting
Odense, Denmark
Contact: Lilian B Ousager
Department of Pahology	Recruiting
Svendborg, Denmark
Contact: Michael Hardt-Madsen
Department of Pathology	Recruiting
Sønderborg, Denmark
Contact: Christian Ladefoged
Department of Clinical Genetics	Recruiting
Vejle, Denmark
Contact: Steen Kølvraa
Department of Pathology	Recruiting
Vejle, Denmark
Contact: Jan Lindebjerg

Sponsors and Collaborators

Vejle Hospital

More Information

No publications provided

Responsible Party:	Vejle Hospital
ClinicalTrials.gov Identifier:	NCT01216930 History of Changes
Other Study ID Numbers:	MS-LS-DK-01, 10-5156
Study First Received:	October 6, 2010
Last Updated:	May 8, 2012
Health Authority:	Denmark: The National Board of Health

Additional relevant MeSH terms:

Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases

Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 24, 2012