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 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.

Study Overview

• Status: Unknown
• Conditions: Colon Cancer

Detailed Description

Primary Objective • To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colorectal 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 colorectal 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 colorectal cancer.
• To compare the performance of ColoPrint vs the clinical risk assessment in estimating the 5-year relapse rate.
• Assess the impact of ColoPrint on adjuvant chemotherapy treatment decisions in stage 2 colorectal cancer patients
• Compare the ColoPrint results from fresh RNARetain colorectal tumor specimens to the matched formalin-fixed paraffin-embedded tissue (FFPE) colon tumor specimens for concordance.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• Austria
  • Feldkirch, Austria
    • Landeskrankenhaus Feldkirch
  • Linz, Austria
    • Krankenhaus der Elisabethinen
  • Vienna, Austria
    • Medical University of Vienna
• China
  • Hong Kong, China
    • University of Hong Kong/ Queen Mary Hospital
• Denmark
  • Odense, Denmark
    • Odense Universitetshospital
• France
  • Montpellier, France
    • CRLC Val d'Aurelle-Paul Lamarque
• Germany
  • Munich, Germany
    • Klinikum rechts der Isar
• Japan
  • Hamamatsu, Japan
    • Matsuda Hospital
• Netherlands
  • Alkmaar, Netherlands
    • Medisch Centrum Alkmaar
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Hoorn, Netherlands
    • Westfriesgasthuis
  • Leiden, Netherlands
    • LUMC
• Spain
  • Barcelona, Spain
    • Vall d' Hebron University Hospital
  • L'Hospitalet de Llobregat, Spain
    • IDIBELL Institut Catala d'Oncologia (ICO)
• Sweden
  • Uppsala, Sweden
    • Immunology Akademiska sjukhuset/ University Hospital
• Switzerland
  • Baden, Switzerland
    • Kantonsspital Baden
• United Kingdom
  • Norwich, United Kingdom
    • Norfolk and Norwich University Hospital
  • Oxford, United Kingdom
    • University of Oxford
• United States
  • California
    • Glendale, California, United States, 91204
      • Glendale Memorial Hospital
    • Laguna Hills, California, United States, 92653
      • South Orange County Surgical Medical Group
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Center
    • Roseville, California, United States, 95661
      • Sutter Roseville Medical Center /Research
    • Sacramento, California, United States, 95816
      • Sutter Cancer Center
    • Sacramento, California, United States, 95817
      • UC Davis Cancer Center
    • San Diego, California, United States, 92037
      • Scripps Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Georgia
    • Riverdale, Georgia, United States, 30274
      • Atlanta Colon and Rectal Surgery
  • New York
    • Bronx, New York, United States
      • Albert Einstein College of Medicine, Montefiore Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Ohio State University
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • Franciscan Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients recruited from participating hospitals worldwide

Description

Inclusion Criteria:

• age ≥ 18 years
• adenocarcinoma of the colon or rectum
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
• 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
• To compare the performance of ColoPrint vs the clinical risk assessment in estimating the 5-year relapse rate.	The enrolment period will be 6 years
• Assess the impact of ColoPrint on adjuvant chemotherapy treatment decisions in stage 2 colorectal cancer patients	The enrolment period will be 6 years
• Compare the ColoPrint results from fresh RNARetain colorectal tumor specimens to the matched formalin-fixed paraffin-embedded tissue (FFPE) colon tumor specimens for concordance.	The enrolment period will be 6 years

Collaborators and Investigators

• Sponsor: Agendia
• Investigators: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 15, 2009
• First Posted (Estimate): May 18, 2009

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: prospective; gene expression; genomic profiling; ColoPrint; adenocarcinoma colon; recurrence risk assessment
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Recurrence; Colonic Neoplasms
• Other Study ID Numbers: CP-060-CR