Clinical trial NCT00903565: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Keywords: genomic profiling
gene expression
ColoPrint
adenocarcinoma colon
recurrence risk assessment
prospective
Lead sponsor: Agendia
Sponsor class: INDUSTRY
First posted: 2009-05-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited from participating hospitals worldwide

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.

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

Primary outcomes:
measure: To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colorectal cancer.
timeFrame: The enrolment period will be 6 years
Secondary outcomes:
measure: • To assess the feasibility of using the ColoPrint test in the clinical setting.
timeFrame: The enrolment period will be 6 years
measure: • To compare the risk assessment in stage II patients using the ColoPrint profile vs a clinical risk assessment
timeFrame: The enrolment period will be 6 years
measure: • To establish the proportion of low-risk and high-risk ColoPrint profiles in stage II colorectal cancer patients in various countries.
timeFrame: The enrolment period will be 6 years
measure: • To investigate therapy as a potential confounding factor for ColoPrint results.
timeFrame: The enrolment period will be 6 years
measure: • To assess the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage III colorectal cancer.
timeFrame: The enrolment period will be 6 years
measure: • To compare the performance of ColoPrint vs the clinical risk assessment in estimating the 5-year relapse rate.
timeFrame: The enrolment period will be 6 years
measure: • Assess the impact of ColoPrint on adjuvant chemotherapy treatment decisions in stage 2 colorectal cancer patients
timeFrame: The enrolment period will be 6 years
measure: • Compare the ColoPrint results from fresh RNARetain colorectal tumor specimens to the matched formalin-fixed paraffin-embedded tissue (FFPE) colon tumor specimens for concordance.
timeFrame: The enrolment period will be 6 years
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Memorial Hospital
state: California
city: Laguna Hills
country: United States
facility: South Orange County Surgical Medical Group
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Roseville
country: United States
facility: Sutter Roseville Medical Center /Research
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Riverdale
country: United States
facility: Atlanta Colon and Rectal Surgery
state: Georgia
city: Bronx
country: United States
facility: Albert Einstein College of Medicine, Montefiore Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Tacoma
country: United States
facility: Franciscan Research Center
state: Washington
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Hong Kong
country: China
facility: University of Hong Kong/ Queen Mary Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Montpellier
country: France
facility: CRLC Val d'Aurelle-Paul Lamarque
city: Munich
country: Germany
facility: Klinikum Rechts Der Isar
city: Hamamatsu
country: Japan
facility: Matsuda Hospital
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Hoorn
country: Netherlands
facility: Westfriesgasthuis
city: Leiden
country: Netherlands
facility: LUMC
city: Barcelona
country: Spain
facility: Vall d' Hebron University Hospital
city: L'Hospitalet de Llobregat
country: Spain
facility: IDIBELL Institut Catala d'Oncologia (ICO)
city: Uppsala
country: Sweden
facility: Immunology Akademiska sjukhuset/ University Hospital
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: Institut Català D´Oncologia, L'Hospitalet Barcelona
name: Ramon Salazar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chief, Division of Hematology/Oncology, Georgetown University Hospital Washington
name: John L Marshall, MD
role: PRINCIPAL_INVESTIGATOR
References: