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Identification of New Colorectal Cancer Genes

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.
ClinicalTrials.gov Identifier: NCT00582335
Recruitment Status : Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to define new genes for family risks of developing colon cancer.

Condition or disease
Colorectal Cancer

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.


Study Design

Study Type : Observational
Actual Enrollment : 337 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Identification of New Colorectal Cancer Genes
Study Start Date : February 1998
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Evidence of mutations in selected candidate genes [ Time Frame: 10 years 10 months ]

Biospecimen Retention:   Samples With DNA
Blood Tissue (tumor)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582335     History of Changes
Other Study ID Numbers: 98-003
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

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

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