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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: March 28, 2014
Last verified: March 2014
  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:


Further study details as provided by Vejle Hospital:

Estimated Enrollment: 1700
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
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
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: 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

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: March 28, 2014
Health Authority: Denmark: The National Board of Health

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

ClinicalTrials.gov processed this record on November 23, 2014