Colorectal CancerNCT01793805
NSABP Patient Registry and Biospecimen Profiling Repository
An observational study of Colorectal Cancer, run by NSABP Foundation Inc at 46 sites in United States.
Trial summary
This is a study to collect and analyze tissue specimens from metastatic colorectal cancer (mCRC) patients for the development of a molecularly profiled tissue repository for the primary purpose of maintaining a patient registry for future clinical trials based on the molecular profile of the tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 3,232 participants
- Where
- 46 sitesUnited States
- Study dates
- Feb 2013to Mar 2022
- How long will I take part?
- 2 Years
- 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: Metastatic colorectal cancer patients.
Who may be able to join
- The patient must have a diagnosis of metastatic colorectal adenocarcinoma.
- Representative formalin-fixed paraffin-embedded (FFPE) tissue blocks from the primary colorectal tumor surgery with corresponding pathology report must be available for release by the local pathology department (an adequate amount of tumor tissue is required for analysis). If available for release, a separate FFPE tissue block from an uninvolved margin of colorectal resection (normal tissue) is also requested.
- The patient must have a life-expectancy of greater than or equal to 6 months.
Who cannot join
- History of non-CRC malignancy unless the patient is considered by the physician to be disease-free and at low risk for recurrence.
- Known comorbid medical conditions that would preclude investigational treatment (e.g., active hepatitis B or C; symptomatic cardiac disease; renal insufficiency; bone marrow impairment).
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude investigational treatment.
- Colonoscopy biopsies or diagnostic core biopsy procedures without surgery or resection.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
Randolph Hospital
Asheboro, North Carolina, 27203
Mission Hospitals
Asheville, North Carolina, 28801
Medstar Franklin Square Medical Center, Weinberg Cancer Institute
Baltimore, Maryland, 21237
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, 83712
Roper Hospital
Charleston, South Carolina, 29401
Carolinas Medical Center/Levine Cancer Center
Charlotte, North Carolina, 28203
Presbyterian Hospital
Charlotte, North Carolina, 28233
Decatur Memorial Hospital
Decatur, Illinois, 62526
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Michigan State University
East Lansing, Michigan, 48824
Sanford Medical Center
Fargo, North Dakota, 58122
University of Florida
Gainesville, Florida, 32610
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, 49503
CCOP, St. Vincent Hospital
Green Bay, Wisconsin, 54301
CCOP - Cone Health Cancer Center
Greensboro, North Carolina, 27403
Cancer Centers of the Carolinas (International)
Greenville, South Carolina, 29615
Virginia Oncology Associates - Hampton
Hampton, Virginia, 23666
High Point Regional Hospital
High Point, North Carolina, 27261
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
CCOP, Kalamazoo, MI
Kalamazoo, Michigan, 49007
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660
CCOP, Marshfield Clinic
Marshfield, Wisconsin, 54449
Aurora Health Care
Milwaukee, Wisconsin, 53215
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
UF Cancer Center at Orlando Health
Orlando, Florida, 32806
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, 28374
Allegheny General Hospital/Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Kootenai Health Cancer Services
Post Falls, Idaho, 83854
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320
MBCCOP, Virginia Commonwealth University
Richmond, Virginia, 23298
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Kaiser Permanente-San Diego
San Diego, California, 92120
Memorial University Medical Center
Savannah, Georgia, 31404
Holy Cross Hospital
Silver Spring, Maryland, 20910
CCOP - Sanford Research
Sioux Falls, South Dakota, 57104
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Kaiser Permanente-Vallejo
Vallejo, California, 94589
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611
CCOP Forsyth Memorial Hospital
Winston-Salem, North Carolina, 27103
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
This is a study to collect and analyze tissue specimens from metastatic colorectal cancer (mCRC) patients for the development of a molecularly profiled tissue repository for the primary purpose of maintaining a patient registry for future clinical trials based on the molecular profile of the tumors. The main purpose of testing these tissue specimens is to identify genetic alterations or biomarkers associated with colorectal cancer such that if new agent(s) become available, particularly those that target these genetic alterations/biomarkers, participants may be offered the opportunity to take part in a National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment protocol.
Read the detailed description
Tissue blocks from the primary tumor site and an uninvolved margin of resection (normal tissue) from consenting patients will be submitted and stored at the NSABP Division of Pathology, in the NSABP Biospecimen Profiling Repository. Tissue specimens will be used to profile molecular characteristics, including actionable mutations most commonly identified in colorectal cancer. Specimens may be further interrogated by other methods to discover additional mechanisms and targetable genetic alterations that may predict sensitivity or resistance to drug therapies.
The repository will be populated, maintained, and analyzed through continuous patient recruitment. Patient tumor specimens will be interrogated to characterize an individual's molecular profile. At a future date for discovery purposes, the normal tissue may be profiled for comparison with the profile of the tumor tissue. NSABP will hold a database with molecular profiles and relevant patient information. As agents become available for clinical study, particularly those matching specified profiles, the treating physician will be contacted so that the patient may be offered participation in that trial via a separate consent process. Each NSABP trial will have a defined molecular profile for entry which will be specific to the agent(s) under study. The MPR-1 patient registry and tissue repository and all treatment protocols associated with MPR-1 are being developed as part of the NSABP Oncology-Genome Assessment Guided Medicine (N-GAMe) Program.
This registry and repository platform uses a translational science approach for more personalized therapy for patients with mCRC. This analysis provides an individual molecular profile in an attempt to direct each patient's treatment based on the pattern of genetic alterations. These efforts also may aid in the discovery of with or without new gene targets for future drug development.
Approximately 1000-2000 tumor (with or without) normal tissue specimens from living mCRC patients will be collected, stored, and analyzed as part of this biospecimen repository. It is anticipated that 200-400 participants will be registered within the first year.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Colorectal Cancer Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize common genetic/molecular profiles associated with colorectal cancer (CRC)
This is a living registry with no end date provided continued funding.
Measured: From start of study through study completion at approximately 6 months
Secondary outcomes (2)
To identify subpopulations of registry patients on the basis of their molecular profiles that may be eligible for participation in available NSABP clinical trials involving novel agents
Measured: From start of study through study completion at approximately 6 months
To conduct further analysis of tumor samples for the discovery of new potential targets and mechanisms of drug resistance
Measured: From start of study through study completion at approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,232 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Norman Wolmark, MD, Principal investigator, NSABP Foundation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793805
- Sponsor's protocol ID
- NSABP MPR-1
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2013
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSABP Patient Registry and Biospecimen Profiling Repository
- ClinicalTrials.gov ID
- NCT01793805
- Acronym / sponsor ID
- NSABP MPR-1
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,232 participants (actual)
- Lead sponsor
- NSABP Foundation IncResearch network
- Study start
- Feb 2013
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 18 Feb 2013 (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.
This is a study to collect and analyze tissue specimens from metastatic colorectal cancer (mCRC) patients for the development of a molecularly profiled tissue repository for the primary purpose of maintaining a patient registry for future clinical trials based on the molecular profile of the tumors. The main purpose of testing these tissue specimens is to identify genetic alterations or biomarkers associated with colorectal cancer such that if new agent(s) become available, particularly those that target these genetic alterations/biomarkers, participants may be offered the opportunity to take part in a National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment protocol.
Detailed description
Tissue blocks from the primary tumor site and an uninvolved margin of resection (normal tissue) from consenting patients will be submitted and stored at the NSABP Division of Pathology, in the NSABP Biospecimen Profiling Repository. Tissue specimens will be used to profile molecular characteristics, including actionable mutations most commonly identified in colorectal cancer. Specimens may be further interrogated by other methods to discover additional mechanisms and targetable genetic alterations that may predict sensitivity or resistance to drug therapies.
The repository will be populated, maintained, and analyzed through continuous patient recruitment. Patient tumor specimens will be interrogated to characterize an individual's molecular profile. At a future date for discovery purposes, the normal tissue may be profiled for comparison with the profile of the tumor tissue. NSABP will hold a database with molecular profiles and relevant patient information. As agents become available for clinical study, particularly those matching specified profiles, the treating physician will be contacted so that the patient may be offered participation in that trial via a separate consent process. Each NSABP trial will have a defined molecular profile for entry which will be specific to the agent(s) under study. The MPR-1 patient registry and tissue repository and all treatment protocols associated with MPR-1 are being developed as part of the NSABP Oncology-Genome Assessment Guided Medicine (N-GAMe) Program.
This registry and repository platform uses a translational science approach for more personalized therapy for patients with mCRC. This analysis provides an individual molecular profile in an attempt to direct each patient's treatment based on the pattern of genetic alterations. These efforts also may aid in the discovery of with or without new gene targets for future drug development.
Approximately 1000-2000 tumor (with or without) normal tissue specimens from living mCRC patients will be collected, stored, and analyzed as part of this biospecimen repository. It is anticipated that 200-400 participants will be registered within the first year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Colorectal Cancer Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic colorectal cancer patients.
Key inclusion criteria (3 listed)
- The patient must have a diagnosis of metastatic colorectal adenocarcinoma.
- Representative formalin-fixed paraffin-embedded (FFPE) tissue blocks from the primary colorectal tumor surgery with corresponding pathology report must be available for release by the local pathology department (an adequate amount of tumor tissue is required for analysis). If available for release, a separate FFPE tissue block from an uninvolved margin of colorectal resection (normal tissue) is also requested.
- The patient must have a life-expectancy of greater than or equal to 6 months.
Key exclusion criteria (4 listed)
- History of non-CRC malignancy unless the patient is considered by the physician to be disease-free and at low risk for recurrence.
- Known comorbid medical conditions that would preclude investigational treatment (e.g., active hepatitis B or C; symptomatic cardiac disease; renal insufficiency; bone marrow impairment).
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude investigational treatment.
- Colonoscopy biopsies or diagnostic core biopsy procedures without surgery or resection.
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 characterize common genetic/molecular profiles associated with colorectal cancer (CRC)
Time frame: From start of study through study completion at approximately 6 months
This is a living registry with no end date provided continued funding.
2 secondary outcomes
To identify subpopulations of registry patients on the basis of their molecular profiles that may be eligible for participation in available NSABP clinical trials involving novel agents
Time frame: From start of study through study completion at approximately 6 months
To conduct further analysis of tumor samples for the discovery of new potential targets and mechanisms of drug resistance
Time frame: From start of study through study completion at approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
Norman Wolmark, MD principal investigator
NSABP Foundation Inc
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by NSABP Foundation Inc at 46 sites in United States.
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 4 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: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 characterize common genetic/molecular profiles associated with colorectal cancer (CRC) (time frame: From start of study through study completion at approximately 6 months). 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 31 Mar 2022.