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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer

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Trial Information

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


Primary Objective

• To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients
with stage II colon cancer.

Secondary Objectives

- To assess the feasibility of using the ColoPrint test in the clinical setting.

- To compare the risk assessment in stage II patients using the ColoPrint profile vs a
clinical risk assessment based on 1) Investigator's assessment of risk and 2) ASCO
high-risk recommendations (T4 lesions, perforation / obstruction, inadequate node
sampling (less than 12 nodes) or poorly differentiated histology).

- To establish the proportion of low-risk and high-risk ColoPrint profiles in stage II
colon cancer patients in various countries.

- To investigate therapy as a potential confounding factor for ColoPrint results.

- To assess the performance of ColoPrint in estimating the 3-year relapse rate in
patients with stage III colon cancer.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Ramon Salazar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Català D´Oncologia, L'Hospitalet Barcelona

Authority:

Spain: Comité Ético de Investigación Clínica

Study ID:

CP-060-CR

NCT ID:

NCT00903565

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Colon Cancer
  • genomic profiling
  • gene expression
  • ColoPrint
  • adenocarcinoma colon
  • recurrence risk assessment
  • prospective
  • Colonic Neoplasms
  • Recurrence

Name

Location

Wake Forest UniversityWinston-Salem, North Carolina  27103
MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Colorado Cancer CenterDenver, Colorado  80262
Sutter Cancer CenterSacramento, California  95816
Long Beach Memorial Medical CenterLong Beach, California  90806
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Scripps Cancer CenterLa Jolla, California  92037
Ohio State UniversityColumbus, Ohio  43210
Glendale Memorial HospitalGlendale, California  91204
UC Davis Cancer CenterSacramento, California  95817
University of MiamiMiami, Florida  33136
Georgetown University HospitalWashington, District of Columbia  20007
Franciscan Research CenterTacoma, Washington  98405
South Orange County Surgical Medical GroupLaguna Hills, California  92653
Sutter Roseville Medical Center /ResearchRoseville, California  95661
Atlanta Colon and Rectal SurgeryRiverdale, Georgia  30274
Albert Einstein College of Medicine, Montefiore Medical CenterBronx, New York