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Molecular Screening for Lynch Syndrome in Southern Denmark

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01216930
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : September 14, 2015
Information provided by (Responsible Party):
Vejle Hospital

Brief 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.

Condition or disease Intervention/treatment
Colorectal Cancer Lynch Syndrome HNPCC Other: Observation

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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Screening for Lynch Syndrome in Southern Denmark
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
All colorectal cancer patients Other: Observation

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All colorectal cancer patients in the geographical region of southern Denmark

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01216930

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Department of Pathology
Esbjerg, Denmark
Department of Clinical Genetics
Odense, Denmark
Department of Pathology
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

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Responsible Party: Vejle Hospital Identifier: NCT01216930     History of Changes
Other Study ID Numbers: MS-LS-DK-01
10-5156 ( Other Grant/Funding Number: Region of Southern Denmark )
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases