Identification of New Colorectal Cancer Genes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582335
First received: December 21, 2007
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to define new genes for family risks of developing colon cancer.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Identification of New Colorectal Cancer Genes

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Evidence of mutations in selected candidate genes [ Time Frame: 10 years 10 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood Tissue (tumor)


Enrollment: 337
Study Start Date: February 1998
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Colorectal cancer is one of the most significant causes of cancer morbidity and mortality in the United States. In 1997, approximately 130,000 men and woman were diagnosed with colorectal cancer (fourth most common cancer site) and approximately 55,000 died of this disease (second most common cause of cancer deaths); (Cancer Facts & Figures, 1997).

Genetic factors clearly contribute to the etiology of colorectal cancer. Because there is evidence to suggest genetically determined susceptibility to colorectal cancer exists in a proportion of newly diagnosed cases each year, we are conducting a study to identify new genes that are associated with an increased susceptibility to familial colorectal cancer by analysis of families with a clustering of colorectal cancers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

families seen at MSKCC with at least two first-degree relatives affected with colorectal cancer

Criteria

Inclusion Criteria:

  • Age 18 years or greater
  • Able to provide informed consent
  • Any family in which a minimum of two first-degree relatives either are, or have previously been, affected with primary colorectalcancer. These "minimum inclusion criteria" must be met within three generations of the proband or kindreds in which colorectal cancer and lymphoma or renal cell cancer are present or in kindreds in which lymphoma alone or lymphoma and renal cell cancer are present

Exclusion Criteria:

  • Age less than 18 years
  • Family not at increased risk for familial colorectal cancer (see Section 4.1)
  • Family with a hereditary polyposis syndrome (e.g. classic FAP)
  • Not able to provide informed consent
  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: NCT00582335

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Kenneth Offit, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582335     History of Changes
Other Study ID Numbers: 98-003
Study First Received: December 21, 2007
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Colorectal cancer
Genetic testing
Genetic mutations

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014