Trial record 3 of 36 for:    "Lynch syndrome"

Molecular Screening for Lynch Syndrome in Denmark

This study is currently recruiting participants.
Verified March 2014 by Vejle Hospital
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01845753
First received: April 30, 2013
Last updated: March 28, 2014
Last verified: March 2014
  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 ]

Estimated Enrollment: 5000
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (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 Denmark

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01845753

Contacts
Contact: Lars Henrik Jensen, MD PhD +4579406802 lars.henrik.jensen@rsyd.dk

Locations
Denmark
Department of Pathology Recruiting
Aalborg, Denmark
Contact: Mogens Vyberg         
Department of Clinical Genetics Recruiting
Aarhus, Denmark
Contact: Anne-Bine Skytte         
Department of Pathology Recruiting
Aarhus, Denmark
Contact: Torben Steiniche         
Department of Pathology Recruiting
Esbjerg, Denmark
Contact: Katrine U Hansen         
Department of Pathology Recruiting
Hjoerring, Denmark
Contact: Lars J Joergensen         
Department of Clinical Genetics Recruiting
Odense, Denmark
Contact: Lilian B Ousager         
Department of Pathology Recruiting
Odense, Denmark
Contact: Tine Plato         
Department of Pathology Recruiting
Sønderborg, Denmark
Contact: Christian Ladefoged         
Vejle Hospital Recruiting
Vejle, Denmark, 7100
Contact: Lars Henrik Jensen, MD PhD       lars.henrik.jensen@rsyd.dk   
Principal Investigator: Lars Henrik Jensen, MD PhD         
Department of Clinical Genetics Recruiting
Vejle, Denmark
Contact: Anders Bojesen         
Department of Pathology Recruiting
Vejle, Denmark
Contact: Jan Lindebjerg         
Sponsors and Collaborators
Vejle Hospital
  More Information

No publications provided

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
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 April 17, 2014