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Molecular Screening for Lynch Syndrome in Denmark

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01845753
First Posted: May 3, 2013
Last Update Posted: December 22, 2016
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.
Information provided by (Responsible Party):
Vejle Hospital
  Purpose

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 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 Denmark

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Rate of Lynch Syndrome in a population of primary colorectal cancer [ Time Frame: 1 year ]

Enrollment: 5000
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All colorectal cancer patients Other: Observation
Observation

  Eligibility

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 Denmark
Criteria

Inclusion Criteria:

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

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): NCT01845753


Locations
Denmark
Department of Pathology
Aalborg, Denmark
Department of Clinical Genetics
Aarhus, Denmark
Department of Pathology
Aarhus, Denmark
Department of Pathology
Esbjerg, Denmark
Department of Pathology
Hjoerring, Denmark
Department of Clinical Genetics
Odense, Denmark
Department of Pathology
Odense, Denmark
Department of Pathology
Sønderborg, Denmark
Vejle Hospital
Vejle, Denmark, 7100
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: NCT01845753     History of Changes
Other Study ID Numbers: MS-LS-DK-02
First Submitted: April 30, 2013
First Posted: May 3, 2013
Last Update Posted: December 22, 2016
Last Verified: December 2016

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