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



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:September 2008
End Date:December 2019

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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.

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.

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
We found this trial at
18
sites
Laguna Hills, California 92653
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Aurora, Colorado 80045
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Bronx, NY
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Feldkirch, 6800
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Glendale, California 91204
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Houston, Texas 77030
Principal Investigator: George Chang, MD
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Long Beach, California 90801
Principal Investigator: Imad Shbeeb
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Long Beach, CA
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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Riverdale, Georgia 30274
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Roseville, California 95661
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Roseville, CA
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Sacramento, California 95816
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Sacramento, CA
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Sacramento, California 95817
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San Diego, California 92121
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Tacoma, Washington 98405
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Winston-Salem, North Carolina 27157
Principal Investigator: Edward Levine
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Winston-Salem, NC
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