Breast CancerNCT00003329
Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer
An observational study of Breast Cancer and Colorectal Cancer, run by Eastern Cooperative Oncology Group at 32 sites in United States.
Trial summary
RATIONALE: Identification of genes that may be associated with developing certain types of cancer may someday provide important information about a person's risk of getting cancer. Read more about this study
- Who is it for?
- Ages 0 to 120 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Lung Cancer
- What is being tested?
- gene mapping
- How many people
- 4,000 participants
- Where
- 32 sitesUnited States
- Study dates
- 7 Apr 1998to Dec 2007
- 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 0 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed colon, lung, prostate, or invasive breast cancer
- No ductal or lobular carcinoma in situ of the breast only
- Patient and natural full sibling must have (or have had) cancer of the same type
- Participants in E-3Y92 not eligible
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Not specified
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Fox Valley Hematology and Oncology - East Grant Street
Appleton, Wisconsin, 54911-3496
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital
Boca Raton, Florida, 33486
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, 60612
Finger Lakes Hematology and Oncology
Clifton Springs, New York, 14432
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, 60201-1781
Front Range Cancer Specialists
Fort Collins, Colorado, 80528
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, 33805
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, 53405
Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
Rancho Mirage, California, 92270
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, 08043
Jennersville Regional Hospital
West Grove, Pennsylvania, 19390-9499
About this study
Official title: ECOG Laboratory Study: Mapping Interactive Cancer Susceptibility Loci
RATIONALE: Identification of genes that may be associated with developing certain types of cancer may someday provide important information about a person's risk of getting cancer.
PURPOSE: This clinical trial is studying to see if certain genes may be associated with cancer in patients with cancer of the breast, prostate, lung, or colon and siblings of these patients.
Read the detailed description
OBJECTIVES:
- Gather allele-sharing statistics at approximately 100 candidate loci throughout the human genome most likely to influence genetic risk of cancer.
- Use these allele-sharing statistics to test the interaction of each locus individually with cancer-associated, rare alleles of HRAS1.
- Generalize this approach for one of four cancers (breast, colon, lung, or prostate), using allele-sharing statistics to test the interaction of each locus with every other locus.
- Replicate positive results in a distinct set of sibling pairs with cancer.
- Examine, when loci contributing to risk are detected, the influence of this genetic background on clinical outcomes, such as survival.
OUTLINE: Each patient-sibling pair completes a family history questionnaire about the incidence of cancer in the family. Blood samples are obtained from both the patient and the sibling (and both living parents, if available).
The blood samples are genotyped using approximately 300 micro-satellite markers flanking 100 candidate genes previously implicated in genetic risk for cancer. Certain loci are a priority due to their association with HRAS1: BRCA1 and all known mismatch repair loci; other repair genes, such as ATM; the Bloom's syndrome locus; and the XRCC group. Other genes are also mapped.
Patients do not receive the results of the genetic testing and the results do not influence the type and duration of treatment.
Patients only are followed annually.
PROJECTED ACCRUAL: This study will accrue 1,000 patient-sibling pairs for breast cancer. After 18 months, another 1,000 patient-sibling pairs will be accrued for breast cancer. Therefore, up to 2,000 patient-sibling pairs will be accrued over 5 years. (Feasibility of accruing pairs for lung, colon, and prostate cancer is being assessed.)
- Conditions
- Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer
- Being tested
- gene mapping
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage III non-small cell lung cancer, limited stage small cell lung cancer, extensive stage small cell lung cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Colonic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene mappingGenetic
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 start7 Apr 1998
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003329
- Sponsor's protocol ID
- CDR0000066283
- Other IDs
- U10CA021115, ECOG-1Y97
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 15 Jun 2023
- Results posted
- No
Publications
Larson GP, Ding Y, Cheng LS, Lundberg C, Gagalang V, Rivas G, Geller L, Weitzel J, MacDonald D, Archambeau J, Slater J, Neuberg D, Daly MB, Angel I, Benson AB 3rd, Smith K, Kirkwood JM, O'Dwyer PJ, Raskay B, Sutphen R, Drew R, Stewart JA, Werndli J, Johnson D, Ruckdeschel JC, Elston RC, Krontiris TG. Genetic linkage of prostate cancer risk to the chromosome 3 region bearing FHIT. Cancer Res. 2005 Feb 1;65(3):805-14.
PubMed 15705877Krontiris TG, Larson M, Weitzel JN, et al.: Mapping interactive cancer susceptibility loci: Eastern Cooperative Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A2147, 560a, 1998.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECOG Laboratory Study: Mapping Interactive Cancer Susceptibility Loci
- ClinicalTrials.gov ID
- NCT00003329
- Acronym / sponsor ID
- CDR0000066283
- Conditions
- Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Apr 1998 (actual)
- Primary completion
- Dec 2007 (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: Identification of genes that may be associated with developing certain types of cancer may someday provide important information about a person's risk of getting cancer.
PURPOSE: This clinical trial is studying to see if certain genes may be associated with cancer in patients with cancer of the breast, prostate, lung, or colon and siblings of these patients.
Detailed description
OBJECTIVES:
- Gather allele-sharing statistics at approximately 100 candidate loci throughout the human genome most likely to influence genetic risk of cancer.
- Use these allele-sharing statistics to test the interaction of each locus individually with cancer-associated, rare alleles of HRAS1.
- Generalize this approach for one of four cancers (breast, colon, lung, or prostate), using allele-sharing statistics to test the interaction of each locus with every other locus.
- Replicate positive results in a distinct set of sibling pairs with cancer.
- Examine, when loci contributing to risk are detected, the influence of this genetic background on clinical outcomes, such as survival.
OUTLINE: Each patient-sibling pair completes a family history questionnaire about the incidence of cancer in the family. Blood samples are obtained from both the patient and the sibling (and both living parents, if available).
The blood samples are genotyped using approximately 300 micro-satellite markers flanking 100 candidate genes previously implicated in genetic risk for cancer. Certain loci are a priority due to their association with HRAS1: BRCA1 and all known mismatch repair loci; other repair genes, such as ATM; the Bloom's syndrome locus; and the XRCC group. Other genes are also mapped.
Patients do not receive the results of the genetic testing and the results do not influence the type and duration of treatment.
Patients only are followed annually.
PROJECTED ACCRUAL: This study will accrue 1,000 patient-sibling pairs for breast cancer. After 18 months, another 1,000 patient-sibling pairs will be accrued for breast cancer. Therefore, up to 2,000 patient-sibling pairs will be accrued over 5 years. (Feasibility of accruing pairs for lung, colon, and prostate cancer is being assessed.)
Study design
Who may qualify
- Ages
- 0 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| gene mapping | Genetic | – |
Primary outcome
Not reported in the source record.
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 15 Jun 2023.
- Results publication: PubMed 15705877Larson GP, Ding Y, Cheng LS, Lundberg C, Gagalang V, Rivas G, Geller L, Weitzel J, MacDonald D, Archambeau J, Slater J, Neuberg D, Daly MB, Angel I, Benson AB 3rd, Smith K, Kirkwood JM, O'Dwyer PJ, Raskay B, Sutphen R, Drew R, Stewart JA, Werndli J, Johnson D, Ruckdeschel JC, Elston RC, Krontiris TG. Genetic linkage of prostate cancer risk to the chromosome 3 region bearing FHIT. Cancer Res. 2005 Feb 1;65(3):805-14.
- Results publicationKrontiris TG, Larson M, Weitzel JN, et al.: Mapping interactive cancer susceptibility loci: Eastern Cooperative Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A2147, 560a, 1998.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by Eastern Cooperative Oncology Group at 32 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?
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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003329, which also lists 2 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 15 Jun 2023.