Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003648
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
1999-11-01
Brief Title:
Genetic Study of Patients and Families With a History of Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
The Familial Colorectal Neoplasia Collaborative Group
Status:
COMPLETED
Status Verified Date:
2016-07
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 Determination of genetic markers for colorectal cancer may help doctors to identify patients who are at risk
PURPOSE Genetic testing study of patients and families with a history of colorectal cancer to identify patients who are at risk of developing colorectal cancer
PURPOSE Genetic testing study of patients and families with a history of colorectal cancer to identify patients who are at risk of developing colorectal cancer
Detailed Description:
OBJECTIVES I Select patients with colon cancer and families at high-risk for colon cancer and collect leukocyte DNA immortalized cell lines plasma and tumor specimens from these individuals and from control individuals II Develop patient education counseling and follow up plans for these individuals III Compare the frequency of defective DNA mismatch repair in individuals with familial colon cancer versus all colon cancers by using antibodies to the hMSH2 and hMLH1 protein products
OUTLINE This is a multicenter study Patients family members and control individuals complete an extended telephone interview an extended personal interview and an epidemiological survey and contribute a blood specimen Blood and tumor specimens are examined for the specific pattern of immunohistochemical expression of hMSH2 and HMLH1 to determine the frequency or lack of expression of these two protein products Patients may be contacted periodically about every 3 years to update information about health health practices and family history Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
PROJECTED ACCRUAL At least 500-600 families approximately 1500 patients and the same number of matched controls will be accrued for this study
OUTLINE This is a multicenter study Patients family members and control individuals complete an extended telephone interview an extended personal interview and an epidemiological survey and contribute a blood specimen Blood and tumor specimens are examined for the specific pattern of immunohistochemical expression of hMSH2 and HMLH1 to determine the frequency or lack of expression of these two protein products Patients may be contacted periodically about every 3 years to update information about health health practices and family history Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
PROJECTED ACCRUAL At least 500-600 families approximately 1500 patients and the same number of matched controls will be accrued for this study
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 |
|---|---|---|---|
| CDR0000066737 | REGISTRY | PDQ Physician Data Query | None |