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Molecular Screening for Lynch Syndrome in Denmark

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01845753
First received: April 30, 2013
Last updated: November 25, 2015
Last verified: November 2015
  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 ] [ Designated as safety issue: No ]

Enrollment: 5000
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 30, 2013
Last Updated: November 25, 2015
Health Authority: Denmark: The National Board of Health

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

ClinicalTrials.gov processed this record on December 02, 2016