A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint

Description

The aim of this study is to enroll 575 eligible stage II colon cancer patients in order to validate the performance of ColoPrint in estimating 3-year relapse rate. Secondary objectives include comparing the objective risk assessment results from the prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as well as the Investigator's independent assessment. As this is the first prospective study of ColoPrint, this study will also address the logistics and quality assurance of using ColoPrint in clinical practice. The ColoPrint results will not be reported to the physician and/or patient at the time of enrollment. Patient treatment is at the discretion of the physician, adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative. The enrollment period will be 4 years. It is expected that 1800 to 2400 patients will be enrolled in order to obtain 575 analysable stage II samples from eligible patients. Approximately 25-35 clinical sites will be involved worldwide. The statistical analysis will be performed by Agendia and an independent research institute or hospital.

Study Start Date

September 2008

Estimated Completion Date

December 2017

Interventions

No interventions cited

Specialties

  • Internal Medicine: Gastroenterology,Hematology/Oncology
  • Gastroenterology: GI Oncology,Small/Large Intestine
  • Family Medicine: Gastroenterology
  • Physician Assistant: Gastroenterology,Hematology/Oncology

MeSH Terms

  • Colonic Neoplasms
  • Recurrence

Study ID

Agendia -- CP-060-CR

Status

Unknown

Trial ID

NCT00903565

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

1200

Sponsor

Agendia

Inclusion Criteria

  • age >= 18 years
  • adenocarcinoma of the colon
  • stage II-III, planned to be treated with radical surgery

Exclusion Criteria

  • prior malignancy with the exception of basal cell carcinoma or cervical dysplasia
  • any neo-adjuvant therapy
  • synchronous tumors

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (23)

Study Location Distance Name Phone Email
Yale Cancer Center - New Haven, Connecticut 18.1 miles None None None
Yale Cancer Center - New Haven, Connecticut 18.1 miles None None None
Georgetown University Hospital - Washington, District of Columbia 258.0 miles None None None
Ohio State University - Columbus, Ohio 521.8 miles None None None
Wake Forest University - Winston-Salem, North Carolina 523.1 miles None None None
Wake Forest University - Winston-Salem, North Carolina 523.1 miles None None None
Atlanta Colon and Rectal Surgery - Riverdale, Georgia 810.3 miles None None None
Atlanta Colon and Rectal Surgery - Riverdale, Georgia 810.3 miles None None None
University of Miami - Miami, Florida 1,141.0 miles None None None
University of Miami - Miami, Florida 1,141.0 miles None None None
MD Anderson Cancer Center - Houston, Texas 1,475.7 miles None None None
MD Anderson Cancer Center - Houston, Texas 1,475.7 miles None None None
University of Colorado Cancer Center - Aurora, Colorado 1,658.2 miles None None None
Franciscan Research Center - Tacoma, Washington 2,436.7 miles None None None
Scripps Cancer Center - San Diego, California 2,474.1 miles None None None
South Orange County Surgical Medical Group - Laguna Hills, California 2,474.7 miles None None None
Glendale Memorial Hospital - Glendale, California 2,487.6 miles None None None
Glendale Memorial Hospital - Glendale, California 2,487.6 miles None None None
Long Beach Memorial Medical Center - Long Beach, California 2,493.3 miles None None None
Long Beach Memorial Medical Center - Long Beach, California 2,493.3 miles None None None
Sutter Roseville Medical Center Research - Roseville, California 2,520.1 miles None None None
Sutter Cancer Center - Sacramento, California 2,536.1 miles None None None
UC Davis Cancer Center - Sacramento, California 2,536.2 miles None None None

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