A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint (PARSC)
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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint|
|Study Start Date:||September 2008|
• To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colon cancer.
- 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.
|Contact: Laura Dekker, MSc||+31 20 462 1543||Laura.email@example.com|
|Contact: Lisette Stork, MSc||+31 20 462 1526||Lisette.firstname.lastname@example.org|
Show 35 Study Locations
|Principal Investigator:||Ramon Salazar, MD||Institut Català D´Oncologia, L'Hospitalet Barcelona|
|Principal Investigator:||John L Marshall, MD||Chief, Division of Hematology/Oncology, Georgetown University Hospital Washington|