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Molecular Screening for Lynch Syndrome in Southern Denmark

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01216930
First received: October 6, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  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:

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
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

Locations
Denmark
Department of Pathology
Esbjerg, Denmark
Department of Pathology
Odense, Denmark
Department of Clinical Genetics
Odense, Denmark
Department of Pahology
Svendborg, Denmark
Department of Pathology
Sønderborg, Denmark
Department of Clinical Genetics
Vejle, Denmark
Department of Pathology
Vejle, Denmark
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: January 15, 2013
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 19, 2013