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

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ClinicalTrials.gov Identifier: NCT00903565
Recruitment Status : Active, not recruiting
First Posted : May 18, 2009
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Agendia

Tracking Information
First Submitted Date May 15, 2009
First Posted Date May 18, 2009
Last Update Posted Date January 9, 2019
Study Start Date September 2008
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2014)
To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colorectal cancer. [ Time Frame: The enrolment period will be 6 years ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00903565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 18, 2014)
  • • To assess the feasibility of using the ColoPrint test in the clinical setting. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: The enrolment period will be 6 years ]
  • • To investigate therapy as a potential confounding factor for ColoPrint results. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: The enrolment period will be 6 years ]
  • • Assess the impact of ColoPrint on adjuvant chemotherapy treatment decisions in stage 2 colorectal cancer patients [ Time Frame: 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. [ Time Frame: The enrolment period will be 6 years ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint
Official Title A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint
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.

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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients recruited from participating hospitals worldwide
Condition Colon Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 14, 2011)
1200
Original Estimated Enrollment
 (submitted: May 15, 2009)
700
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States,   Austria,   China,   Denmark,   France,   Germany,   Japan,   Netherlands,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00903565
Other Study ID Numbers CP-060-CR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Agendia
Study Sponsor Agendia
Collaborators Not Provided
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
PRS Account Agendia
Verification Date January 2019