Colon CancerPARSCNCT00903565
A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint
An observational study of Colon Cancer, run by Agendia at 35 sites in 12 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- How many people
- 1,200 participants
- Where
- 35 sitesin 12 countries
- Study dates
- Sep 2008to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited from participating hospitals worldwide
Who may be able to join
- age ≥ 18 years
- adenocarcinoma of the colon or rectum
- stage II-III, planned to be treated with radical surgery
Who cannot join
- prior malignancy with the exception of basal cell carcinoma or cervical dysplasia
- any neo-adjuvant therapy
- synchronous tumors
Trial locations and contacts
35 sites in 12 countries.
35 sites in 12 countries
United States17 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Ohio State University
Columbus, Ohio, 43212
Glendale Memorial Hospital
Glendale, California, 91204
MD Anderson Cancer Center
Houston, Texas, 77030
South Orange County Surgical Medical Group
Laguna Hills, California, 92653
Long Beach Memorial Medical Center
Long Beach, California, 90806
University of Miami
Miami, Florida, 33136
Yale Cancer Center
New Haven, Connecticut, 06520
Atlanta Colon and Rectal Surgery
Riverdale, Georgia, 30274
Sutter Roseville Medical Center /Research
Roseville, California, 95661
Sutter Cancer Center
Sacramento, California, 95816
UC Davis Cancer Center
Sacramento, California, 95817
Scripps Cancer Center
San Diego, California, 92037
Franciscan Research Center
Tacoma, Washington, 98405
Albert Einstein College of Medicine, Montefiore Medical Center
The Bronx, New York
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Wake Forest University
Winston-Salem, North Carolina, 27157
Netherlands4 sites
Medisch Centrum Alkmaar
Alkmaar
Medisch Spectrum Twente
Enschede
Westfriesgasthuis
Hoorn
LUMC
Leiden
Austria3 sites
Landeskrankenhaus Feldkirch
Feldkirch
Krankenhaus der Elisabethinen
Linz
Medical University of Vienna
Vienna
Spain2 sites
Vall d' Hebron University Hospital
Barcelona
IDIBELL Institut Catala d'Oncologia (ICO)
L'Hospitalet de Llobregat
United Kingdom2 sites
Norfolk and Norwich University Hospital
Norwich
University of Oxford
Oxford
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Colon Cancer
- Keywords
- genomic profiling, gene expression, ColoPrint, adenocarcinoma colon, recurrence risk assessment, prospective
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colorectal cancer.
Measured: The enrolment period will be 6 years
Secondary outcomes (8)
• To assess the feasibility of using the ColoPrint test in the clinical setting.
Measured: 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
Measured: 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.
Measured: The enrolment period will be 6 years
• To investigate therapy as a potential confounding factor for ColoPrint results.
Measured: 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.
Measured: 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.
Measured: The enrolment period will be 6 years
• Assess the impact of ColoPrint on adjuvant chemotherapy treatment decisions in stage 2 colorectal cancer patients
Measured: 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.
Measured: The enrolment period will be 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agendia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramon Salazar, MD, Principal investigator, Institut Català D´Oncologia, L'Hospitalet BarcelonaJohn L Marshall, MD, Principal investigator, Chief, Division of Hematology/Oncology, Georgetown University Hospital Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903565
- Sponsor's protocol ID
- CP-060-CR
- Acronym
- PARSC
- Status last verified
- Jan 2019
- First submitted
- 15 May 2009
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint
- ClinicalTrials.gov ID
- NCT00903565
- Acronym / sponsor ID
- PARSC / CP-060-CR
- Conditions
- Colon Cancer
- Keywords
- genomic profiling, gene expression, ColoPrint, adenocarcinoma colon, recurrence risk assessment, prospective
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- AgendiaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited from participating hospitals worldwide
Key inclusion criteria (3 listed)
- age ≥ 18 years
- adenocarcinoma of the colon or rectum
- stage II-III, planned to be treated with radical surgery
Key exclusion criteria (3 listed)
- prior malignancy with the exception of basal cell carcinoma or cervical dysplasia
- any neo-adjuvant therapy
- synchronous tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
• 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Related InfoLink provided by the sponsor.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramon Salazar, MD principal investigator
Institut Català D´Oncologia, L'Hospitalet Barcelona
John L Marshall, MD principal investigator
Chief, Division of Hematology/Oncology, Georgetown University Hospital Washington
35 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Agendia at 35 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Netherlands, Austria, Spain, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.