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A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06520 |
| Conditions: |
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Colon Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00903565 |
| Primary Contact: |
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Principal Investigator
Ramon Salazar, MD
Institut Català D´Oncologia, L'Hospitalet Barcelona
Laura Dekker, MSc
Phone: +31 20 462 1543
Email: Laura.dekker@agendia.com
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| Backup Contact: |
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Email: Lisette.stork@agendia.com
Lisette Stork, MSc
Phone: +31 20 462 1526
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| Location Contact: |
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New Haven, Connecticut 06520
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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