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

Sponsor

Agendia (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00903565

Collaborator

(none)

1,200

Enrollment

Locations

135

Duration (Months)

34.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

1200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Outcome Measures

Primary Outcome Measures

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

• 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glendale Memorial Hospital	Glendale	California	United States	91204
2	South Orange County Surgical Medical Group	Laguna Hills	California	United States	92653
3	Long Beach Memorial Medical Center	Long Beach	California	United States	90806
4	Sutter Roseville Medical Center /Research	Roseville	California	United States	95661
5	Sutter Cancer Center	Sacramento	California	United States	95816
6	UC Davis Cancer Center	Sacramento	California	United States	95817
7	Scripps Cancer Center	San Diego	California	United States	92037
8	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
9	Yale Cancer Center	New Haven	Connecticut	United States	06520
10	Georgetown University Hospital	Washington	District of Columbia	United States	20007
11	University of Miami	Miami	Florida	United States	33136
12	Atlanta Colon and Rectal Surgery	Riverdale	Georgia	United States	30274
13	Albert Einstein College of Medicine, Montefiore Medical Center	Bronx	New York	United States
14	Wake Forest University	Winston-Salem	North Carolina	United States	27157
15	Ohio State University	Columbus	Ohio	United States	43212
16	MD Anderson Cancer Center	Houston	Texas	United States	77030
17	Franciscan Research Center	Tacoma	Washington	United States	98405
18	Landeskrankenhaus Feldkirch	Feldkirch		Austria
19	Krankenhaus der Elisabethinen	Linz		Austria
20	Medical University of Vienna	Vienna		Austria
21	University of Hong Kong/ Queen Mary Hospital	Hong Kong		China
22	Odense Universitetshospital	Odense		Denmark
23	CRLC Val d'Aurelle-Paul Lamarque	Montpellier		France
24	Klinikum Rechts Der Isar	Munich		Germany
25	Matsuda Hospital	Hamamatsu		Japan
26	Medisch Centrum Alkmaar	Alkmaar		Netherlands
27	Medisch Spectrum Twente	Enschede		Netherlands
28	Westfriesgasthuis	Hoorn		Netherlands
29	LUMC	Leiden		Netherlands
30	Vall d' Hebron University Hospital	Barcelona		Spain
31	IDIBELL Institut Catala d'Oncologia (ICO)	L'Hospitalet de Llobregat		Spain
32	Immunology Akademiska sjukhuset/ University Hospital	Uppsala		Sweden
33	Kantonsspital Baden	Baden		Switzerland
34	Norfolk and Norwich University Hospital	Norwich		United Kingdom
35	University of Oxford	Oxford		United Kingdom

Sponsors and Collaborators

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