Colorectal CancerNCT00003833
Genetic Study in Patients With Stage II or Stage III Colon Cancer
An observational study of Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 59 sites in 2 countries.
Trial summary
RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer. PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer. Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- DNA stability analysis and gene mapping
- How many people
- 598 participants
- Where
- 59 sitesin 2 countries
- Study dates
- Feb 1999to Aug 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 Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced colon cancer previously participating in NCCTG-914653.
DISEASE CHARACTERISTICS:
- Diagnosis of resectable stage II or III adenocarcinoma of the colon
- Participated in NCCTG-914653
- DNA extracted from both normal and tumor tissue
PATIENT CHARACTERISTICS:
Age
- Under 70
Trial locations and contacts
59 sites in 2 countries.
59 sites in 2 countries
Canada58 sites
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, P3E 5J1
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Hamilton and District Urology Association
Hamilton, Ontario, L8N 1T8
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, J6E 6J2
Lethbridge Cancer Clinic
Lethbridge, Alberta, T1J 1W5
London Health Sciences Centre
London, Ontario, N6A 4G5
Markham Stouffville Hospital
Markham, Ontario, L3P 7T3
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, (P.Q.) H2X 3J4
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
McGill University
Montreal, Quebec, H2W 1S6
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Nanaimo Cancer Clinic
Nanaimo, British Columbia, V9S 2B7
York County Hospital
Newmarket, Ontario, L3Y 2P9
Lions Gate Hospital
North Vancouver, V7L 2P9
North York General Hospital, Ontario
North York, Ontario, M2K 1E1
Male Health Centre/CMX Research Inc.
Oakville, Ontario, L6H 3PI
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, H9R 4S3
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6
Hopital du Saint-Sacrament, Quebec
Québec, Quebec, G1S 4L8
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, G5L 5T1
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Scarborough Hospital - General Site
Scarborough Village, Ontario, M1P 2V5
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6
L'Hopital Laval
Ste-Foy, Quebec, G1V 4G5
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Cape Breton Cancer Centre
Sydney, Nova Scotia, B1P 1P3
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, M5S 1B6
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, V6Z 1Y6
G. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
United States1 site
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805
About this study
Official title: The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer
RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer.
PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer.
Read the detailed description
OBJECTIVES:
- Determine the adverse prognostic significance of 8p allelic imbalance (AI) in patients with colon cancer.
- Determine if patient prognosis is dependent on the region of 8p AI.
- Perform fine mapping studies to further localize the putative tumor suppressor gene(s) on 8p.
- Perform multicolor FISH to examine the role that 8p loss and 8q gain play in the prognosis of patients whose tumors exhibit 8p AI.
OUTLINE: Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.
- Conditions
- Colorectal Cancer
- Being tested
- DNA stability analysis, gene mapping
- Keywords
- stage II colon cancer, 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.
DNA stability analysisGenetic
gene mappingGenetic
| Study group | Role | What they receive |
|---|---|---|
| Normal and tumor tissue pairs | Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies. Receives: Genetic: DNA stability analysis; Genetic: gene mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
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 posted27 Jan 2003 (estimated)
- Study startFeb 1999
- Primary completionAug 2006
- Study completionAug 2006
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
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), NCIC Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Richard M. Goldberg, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003833
- Sponsor's protocol ID
- NCCTG-984654
- Other IDs
- CDR0000066990, CAN-NCIC-CO9PATH
- Status last verified
- Jul 2016
- First submitted
- 1 Nov 1999
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00003833
- Acronym / sponsor ID
- NCCTG-984654
- Conditions
- Colorectal Cancer
- Keywords
- stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), NCIC Clinical Trials Group
- Study start
- Feb 1999
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (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: Genetic studies may help in understanding the genetic processes that cause some types of cancer.
PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer.
Detailed description
OBJECTIVES:
- Determine the adverse prognostic significance of 8p allelic imbalance (AI) in patients with colon cancer.
- Determine if patient prognosis is dependent on the region of 8p AI.
- Perform fine mapping studies to further localize the putative tumor suppressor gene(s) on 8p.
- Perform multicolor FISH to examine the role that 8p loss and 8q gain play in the prognosis of patients whose tumors exhibit 8p AI.
OUTLINE: Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal and tumor tissue pairs | – | Genetic: DNA stability analysis, Genetic: gene mappingMatched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies. |
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced colon cancer previously participating in NCCTG-914653.
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 |
|---|---|---|
| DNA stability analysis | Genetic | Normal and tumor tissue pairs |
| gene mapping | Genetic | Normal and tumor tissue pairs |
Primary outcome
overall survival
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 13 Jul 2016.
Related trials for Colorectal 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
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
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
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.
Richard M. Goldberg, MD study chair
Mayo Clinic
59 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 59 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 13 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 59 sites in Canada, 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?
overall 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?
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 13 Jul 2016.