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Molecular Screening for Lynch Syndrome in Southern Denmark

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ClinicalTrials.gov Identifier: NCT01216930
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : October 2012
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01216930


Locations
Denmark
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
More Information

Responsible Party: Vejle Hospital
ClinicalTrials.gov 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:
Syndrome
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Disease
Pathologic Processes
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