Colorectal CancerNCT00044967
Genetic Study of Young Patients With Colorectal Cancer
An observational study of Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 73 sites in 2 countries.
Trial summary
RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age. PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage… Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- microsatellite instability analysis
- How many people
- 651 participants
- Where
- 73 sitesin 2 countries
- Study dates
- May 2002to Dec 2004
- 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 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients diagnosed with adenocarcinoma of the colon or rectum.
DISEASE CHARACTERISTICS:
- Diagnosis of stage I-III adenocarcinoma of the colon or rectum
- Must have undergone an initial curative resection within the past year
- No colon or rectal cancer resection that does not allow for definitive T or N staging
- No initial post-surgical surveillance colonoscopy prior to study entry
- Must have a pathology specimen, with representative normal and tumor tissues, available for submission to the ACOSOG Central Specimen Bank prior to study entry
- No personal or family history of familial adenomatous polyposis
- No recurrent colorectal cancer
PATIENT CHARACTERISTICS:
Age
- 18 to 49 at first diagnosis
Other
- Must be willing to provide a family cancer history to the study team and continue with follow-up colonoscopic surveillance
- No other malignancy within the past 5 years except completely resected cervical cancer or nonmelanoma skin cancer
- No evidence of recurrence of other prior malignancy
PRIOR CONCURRENT THERAPY:
Radiotherapy
- No prior pelvic radiotherapy for rectal cancer
- No concurrent preoperative pelvic radiotherapy for rectal cancer
Surgery
- See Disease Characteristics
Trial locations and contacts
73 sites in 2 countries.
73 sites in 2 countries
United States71 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Akron General's McDowell Cancer Center
Akron, Ohio, 44302
Fox Valley Surgical Associates at Appleton Medical Center
Appleton, Wisconsin, 54911-3454
Appleton Medical Center
Appleton, Wisconsin, 54911
Northwest Community Hospital
Arlington Heights, Illinois, 60005
Rush Copley Medical Center
Aurora, Illinois, 60504-4206
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
St. Agnes Cancer Center
Baltimore, Maryland, 21229
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, 01805
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
Presbyterian Hospital
Charlotte, North Carolina, 28204
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Sarah Cannon Cancer Center at Parkridge Medical Center
Chattanooga, Tennessee, 37404-3285
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Morton Plant Hospital
Clearwater, Florida, 33756
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Arrowhead Regional Medical Center
Colton, California, 92324-1819
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
Baylor University Medical Center
Dallas, Texas, 75246
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
INOVA Fair Oaks Hospital
Fairfax, Virginia, 22033
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300
Great Lakes Cancer Institute - McLaren
Flint, Michigan, 48532
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, 32610-100277
Surgical Oncology of Northeast Georgia
Gainesville, Georgia, 30501
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Methodist Hospital
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
Central Baptist Hospital
Lexington, Kentucky, 40503-9985
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-7375
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
Memphis, Tennessee, 38120
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Providence Cancer Center
Mobile, Alabama, 36608
Mobile Infirmary Medical Center
Mobile, Alabama, 36640-0460
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-6860
Baptist Hospital
Nashville, Tennessee, 37236
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Integris Oncology Services
Oklahoma City, Oklahoma, 73112
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114-4199
Cancer Center at Creighton University Medical Center
Omaha, Nebraska, 68131-2197
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, 23298-0037
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
Associated Surgeons P.S.
Spokane, Washington, 99204
Sacred Heart Medical Center
Spokane, Washington, 99204
Providence Cancer Center at Holy Family Hospital
Spokane, Washington, 99208
Deaconess Medical Center
Spokane, Washington, 99210-0248
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
Digestive Health Specialists, P.A.
Tupelo, Mississippi, 38801
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, 01655
Canada2 sites
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer
RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age.
PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I, stage II, or stage III colorectal cancer at an early age.
Read the detailed description
OBJECTIVES:
- Evaluate the prognostic significance (e.g., overall survival) of microsatellite instability (MSI) status in patients with early age-of-onset stage I-III colorectal cancer, assuming the presence of a quantitative interaction between MSI status and family history of cancer.
- Evaluate the development of metachronous neoplasms in this patient population.
- Evaluate the histologic features and genetic changes associated with hereditary nonpolyposis colorectal cancer in this patient population.
OUTLINE: This is a multicenter study. Patients are stratified according to family history using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer (positive vs negative).
Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline.
The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance.
Patients may be referred for genetic counseling.
A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.
- Conditions
- Colorectal Cancer
- Being tested
- microsatellite instability analysis
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microsatellite instability analysisGenetic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline.
The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance.
Patients may be referred for genetic counseling. Receives: Genetic: microsatellite instability analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2002
- Primary completionDec 2004
- Study completionDec 2004
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.
- 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
- 651 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
- Jose G. Guillem, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044967
- Sponsor's protocol ID
- ACOSOG-Z0190
- Other IDs
- ACOSOG-Z0190, CDR0000069465
- Status last verified
- Jul 2016
- First submitted
- 6 Sep 2002
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
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
- A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00044967
- Acronym / sponsor ID
- ACOSOG-Z0190
- Conditions
- Colorectal Cancer
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 27 Jan 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: Identifying gene mutations (microsatellite instability) may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age.
PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I, stage II, or stage III colorectal cancer at an early age.
Detailed description
OBJECTIVES:
- Evaluate the prognostic significance (e.g., overall survival) of microsatellite instability (MSI) status in patients with early age-of-onset stage I-III colorectal cancer, assuming the presence of a quantitative interaction between MSI status and family history of cancer.
- Evaluate the development of metachronous neoplasms in this patient population.
- Evaluate the histologic features and genetic changes associated with hereditary nonpolyposis colorectal cancer in this patient population.
OUTLINE: This is a multicenter study. Patients are stratified according to family history using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer (positive vs negative).
Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline.
The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance.
Patients may be referred for genetic counseling.
A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: microsatellite instability analysisPatients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline. The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance. Patients may be referred for genetic counseling. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with adenocarcinoma of the colon or rectum.
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 |
|---|---|---|
| microsatellite instability analysis | Genetic | Group 1 |
Primary outcome
overall survival
Time frame: Up to 2 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.
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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.
Jose G. Guillem, MD study chair
Memorial Sloan Kettering Cancer Center
73 sites in 2 countries: 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 73 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 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 73 sites in United States, Canada. 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?
overall survival (time frame: Up to 2 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 6 Jul 2016.