A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint
PARSC
1 other identifier
observational
1,200
12 countries
35
Brief Summary
The aim of this study is to enroll 785 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. 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 6 years. It is expected that 1800 to 2400 patients will be enrolled in order to obtain 785 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 Extension Study: This will be a prospective study to measure the impact of ColoPrint on adjuvant treatment in stage 2 colorectal cancer patients. After surgery the tumor sample will be shipped in RNA Retain to Agendia. The online Clinical Report Form (CRF) 0 will be completed to document if the patient fulfils the inclusion criteria. Baseline clinical data and the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict without knowing the ColoPrint result will be entered in CRF 1. After completion of CRF1 the ColoPrint result is released. CRF2 will be completed after the final treatment decision has been made. This CRF will capture the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict, impact of ColoPrint and the actual treatment the patient will receive. CRF3 will be completed 12 months after enrolment and will capture the patient status, patient's perceived recurrence risk and decisional conflict. CRF4 and 5 will be completed 3 and 5 years after surgery and will capture the patient status. A sample size of 210 stage 2 colon cancer patients is required to detect a 10% overall treatment change (5% significance and 90% power). Reporting of the Results: Blinded Study; The ColoPrint results will not be reported to the physician and/or patient at the time of enrolment. All samples will be stored in a freezer until 550-575 eligible stage II patients have been enrolled. Samples will then be analyzed in one batch in a blinded fashion from the clinical results. Extension Study; The ColoPrint results will be reported to the physician and patient after CRF1 has been completed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
Longer than P75 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 9, 2019
January 1, 2019
11.3 years
May 15, 2009
January 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colorectal cancer.
The enrolment period will be 6 years
Secondary Outcomes (8)
• To assess the feasibility of using the ColoPrint test in the clinical setting.
The enrolment period will be 6 years
• To compare the risk assessment in stage II patients using the ColoPrint profile vs a clinical risk assessment
The enrolment period will be 6 years
• To establish the proportion of low-risk and high-risk ColoPrint profiles in stage II colorectal cancer patients in various countries.
The enrolment period will be 6 years
• To investigate therapy as a potential confounding factor for ColoPrint results.
The enrolment period will be 6 years
• To assess the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage III colorectal cancer.
The enrolment period will be 6 years
- +3 more secondary outcomes
Eligibility Criteria
Patients recruited from participating hospitals worldwide
You may qualify if:
- age ≥ 18 years
- adenocarcinoma of the colon or rectum
- stage II-III, planned to be treated with radical surgery
You may not qualify if:
- prior malignancy with the exception of basal cell carcinoma or cervical dysplasia
- any neo-adjuvant therapy
- synchronous tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agendialead
Study Sites (35)
Glendale Memorial Hospital
Glendale, California, 91204, United States
South Orange County Surgical Medical Group
Laguna Hills, California, 92653, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Sutter Roseville Medical Center /Research
Roseville, California, 95661, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
UC Davis Cancer Center
Sacramento, California, 95817, United States
Scripps Cancer Center
San Diego, California, 92037, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
University of Miami
Miami, Florida, 33136, United States
Atlanta Colon and Rectal Surgery
Riverdale, Georgia, 30274, United States
Albert Einstein College of Medicine, Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Ohio State University
Columbus, Ohio, 43212, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Franciscan Research Center
Tacoma, Washington, 98405, United States
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Krankenhaus der Elisabethinen
Linz, Austria
Medical University of Vienna
Vienna, Austria
University of Hong Kong/ Queen Mary Hospital
Hong Kong, China
Odense Universitetshospital
Odense, Denmark
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, France
Klinikum Rechts Der Isar
Munich, Germany
Matsuda Hospital
Hamamatsu, Japan
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Westfriesgasthuis
Hoorn, Netherlands
LUMC
Leiden, Netherlands
Vall d' Hebron University Hospital
Barcelona, Spain
IDIBELL Institut Catala d'Oncologia (ICO)
L'Hospitalet de Llobregat, Spain
Immunology Akademiska sjukhuset/ University Hospital
Uppsala, Sweden
Kantonsspital Baden
Baden, Switzerland
Norfolk and Norwich University Hospital
Norwich, United Kingdom
University of Oxford
Oxford, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2009
First Posted
May 18, 2009
Study Start
September 1, 2008
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
January 9, 2019
Record last verified: 2019-01