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

Colon Cancer Clinical Trial

— PARSC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00903565
• Other study ID #: CP-060-CR
• Status: Active, not recruiting
• Start date: September 2008
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Agendia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Recurrence

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Agendia

Countries where clinical trial is conducted

United States,  Austria,  China,  Denmark,  France,  Germany,  Japan,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	• To assess the feasibility of using the ColoPrint test in the clinical setting.		The enrolment period will be 6 years
Secondary	• 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
Secondary	• 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
Secondary	• To investigate therapy as a potential confounding factor for ColoPrint results.		The enrolment period will be 6 years
Secondary	• 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
Secondary	• 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
Secondary	• Assess the impact of ColoPrint on adjuvant chemotherapy treatment decisions in stage 2 colorectal cancer patients		The enrolment period will be 6 years
Secondary	• 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

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