Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003329
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
ECOG Laboratory Study Mapping Interactive Cancer Susceptibility Loci
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Identification of genes that may be associated with developing certain types of cancer may someday provide important information about a persons 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
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 Blooms 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 1000 patient-sibling pairs for breast cancer After 18 months another 1000 patient-sibling pairs will be accrued for breast cancer Therefore up to 2000 patient-sibling pairs will be accrued over 5 years Feasibility of accruing pairs for lung colon and prostate cancer is being assessed
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 Blooms 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 1000 patient-sibling pairs for breast cancer After 18 months another 1000 patient-sibling pairs will be accrued for breast cancer Therefore up to 2000 patient-sibling pairs will be accrued over 5 years Feasibility of accruing pairs for lung colon and prostate cancer is being assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-1Y97 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |