Colorectal CancerNCT00003571
Gene Testing in Patients With Colon Cancer
An observational study of Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 44 sites in United States.
Trial summary
RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer. PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- mutation analysis and tumor replication error analysis
- How many people
- 300 participants
- Where
- 44 sitesUnited States
- Study dates
- Aug 1998to Jan 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients previously enrolled on CALGB-8896.
DISEASE CHARACTERISTICS:
- Patients who received chemotherapy for colon cancer as part of CALGB protocol 8896
- Underwent an initial resection for adenocarcinoma of the colon and were determined to have a high risk of tumor recurrence based upon nodal disease or local extension of tumor with obstruction or perforation due to tumor
- Surgical specimen blocks available, including tumor tissue and normal tissue
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
CCOP - North Shore University Hospital
Manhasset, New York, 11030
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021
Mount Sinai Medical Center, NY
New York, New York, 10029
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
Rhode Island Hospital
Providence, Rhode Island, 02903
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Barnes-Jewish Hospital
St Louis, Missouri, 63110
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial
RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer.
PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer.
Read the detailed description
OBJECTIVES:
- Determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on CALGB protocol 8896.
- Determine the prognostic and predictive values for response to this therapy in these patients.
- Conditions
- Colorectal Cancer
- Being tested
- mutation analysis, tumor replication error analysis
- Keywords
- stage III colon cancer, adenocarcinoma of the colon
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutation analysisGenetic
tumor replication error analysisGenetic
| Study group | Role | What they receive |
|---|---|---|
| Samples of tumor and normal tissue | Samples of tumor and normal tissue are obtained from CALGB 8896 patients. The samples are tested for somatic mutations and tumor replication error (RER) tumor status. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. Receives: Genetic: mutation analysis; Genetic: tumor replication error analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: Up to 10 years
Secondary outcomes (3)
overall survival
Measured: Up to 10 years
tumor replication error status
Measured: Up to 10 years
determine the prognostic and predictive values for response to this therapy
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2003 (estimated)
- Study startAug 1998
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Monica M. Bertagnolli, MD, Study chair, Dana-Farber/Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003571
- Sponsor's protocol ID
- CALGB-9865
- Other IDs
- U10CA031946, CLB-9865, CDR0000066637
- Status last verified
- Jul 2016
- First submitted
- 1 Nov 1999
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Goel A, Arnold CN, Niedzwiecki D, Carethers JM, Dowell JM, Wasserman L, Compton C, Mayer RJ, Bertagnolli MM, Boland CR. Frequent inactivation of PTEN by promoter hypermethylation in microsatellite instability-high sporadic colorectal cancers. Cancer Res. 2004 May 1;64(9):3014-21. doi: 10.1158/0008-5472.can-2401-2.
PubMed 15126336Goel A, Arnold CN, Niedzwiecki D, Chang DK, Ricciardiello L, Carethers JM, Dowell JM, Wasserman L, Compton C, Mayer RJ, Bertagnolli MM, Boland CR. Characterization of sporadic colon cancer by patterns of genomic instability. Cancer Res. 2003 Apr 1;63(7):1608-14.
PubMed 12670912Arnold CN, Goel A, Compton C, Marcus V, Niedzwiecki D, Dowell JM, Wasserman L, Inoue T, Mayer RJ, Bertagnolli MM, Boland CR. Evaluation of microsatellite instability, hMLH1 expression and hMLH1 promoter hypermethylation in defining the MSI phenotype of colorectal cancer. Cancer Biol Ther. 2004 Jan;3(1):73-8. doi: 10.4161/cbt.3.1.590. Epub 2004 Jan 5.
PubMed 14726676Goel A, Arnold CN, Tassone P, Chang DK, Niedzwiecki D, Dowell JM, Wasserman L, Compton C, Mayer RJ, Bertagnolli MM, Boland CR. Epigenetic inactivation of RUNX3 in microsatellite unstable sporadic colon cancers. Int J Cancer. 2004 Dec 10;112(5):754-9. doi: 10.1002/ijc.20472.
PubMed 15386381
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial
- ClinicalTrials.gov ID
- NCT00003571
- Acronym / sponsor ID
- CALGB-9865
- Conditions
- Colorectal Cancer
- Keywords
- stage III colon cancer, adenocarcinoma of the colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1998
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 15 Jul 2003 (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.
RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer.
PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer.
Detailed description
OBJECTIVES:
- Determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on CALGB protocol 8896.
- Determine the prognostic and predictive values for response to this therapy in these patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Samples of tumor and normal tissue | – | Genetic: mutation analysis, Genetic: tumor replication error analysisSamples of tumor and normal tissue are obtained from CALGB 8896 patients. The samples are tested for somatic mutations and tumor replication error (RER) tumor status. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients previously enrolled on CALGB-8896.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mutation analysis | Genetic | Samples of tumor and normal tissue |
| tumor replication error analysis | Genetic | Samples of tumor and normal tissue |
Primary outcome
disease free survival
Time frame: Up to 10 years
3 secondary outcomes
overall survival
Time frame: Up to 10 years
tumor replication error status
Time frame: Up to 10 years
determine the prognostic and predictive values for response to this therapy
Time frame: Up to 10 years
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 6 Jul 2016.
- Background: PubMed 15126336Goel A, Arnold CN, Niedzwiecki D, Carethers JM, Dowell JM, Wasserman L, Compton C, Mayer RJ, Bertagnolli MM, Boland CR. Frequent inactivation of PTEN by promoter hypermethylation in microsatellite instability-high sporadic colorectal cancers. Cancer Res. 2004 May 1;64(9):3014-21. doi: 10.1158/0008-5472.can-2401-2.
- Background: PubMed 12670912Goel A, Arnold CN, Niedzwiecki D, Chang DK, Ricciardiello L, Carethers JM, Dowell JM, Wasserman L, Compton C, Mayer RJ, Bertagnolli MM, Boland CR. Characterization of sporadic colon cancer by patterns of genomic instability. Cancer Res. 2003 Apr 1;63(7):1608-14.
- Results publication: PubMed 14726676Arnold CN, Goel A, Compton C, Marcus V, Niedzwiecki D, Dowell JM, Wasserman L, Inoue T, Mayer RJ, Bertagnolli MM, Boland CR. Evaluation of microsatellite instability, hMLH1 expression and hMLH1 promoter hypermethylation in defining the MSI phenotype of colorectal cancer. Cancer Biol Ther. 2004 Jan;3(1):73-8. doi: 10.4161/cbt.3.1.590. Epub 2004 Jan 5.
- Results publication: PubMed 15386381Goel A, Arnold CN, Tassone P, Chang DK, Niedzwiecki D, Dowell JM, Wasserman L, Compton C, Mayer RJ, Bertagnolli MM, Boland CR. Epigenetic inactivation of RUNX3 in microsatellite unstable sporadic colon cancers. Int J Cancer. 2004 Dec 10;112(5):754-9. doi: 10.1002/ijc.20472.
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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.
Monica M. Bertagnolli, MD study chair
Dana-Farber/Brigham and Women's Cancer Center
44 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 Alliance for Clinical Trials in Oncology at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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?
disease free survival (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003571, which also lists 4 linked publications.
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 6 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.