Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082745
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2004-05-14
Brief Title:
Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Key Adverse Events After Childhood Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer A patients genes may affect the risk of developing complications such as congestive heart failure avascular necrosis stroke and second cancer years after undergoing cancer treatment Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications
Detailed Description:
PRIMARY OBJECTIVES
I To identify key adverse events developing in patients cases with a primary cancer diagnosed at age 21 or younger
II To characterize the key adverse events with respect to the nature of the primary malignancy pathology stage and coded details of the therapeutic protocol
III To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis
IV To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls using constitutional deoxyribonucleic acid DNA and ribonucleic acid RNA from the cases and controls
V To explore the role and nature of gene-environment interaction in the development of key adverse events
OUTLINE
DNA and RNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications
I To identify key adverse events developing in patients cases with a primary cancer diagnosed at age 21 or younger
II To characterize the key adverse events with respect to the nature of the primary malignancy pathology stage and coded details of the therapeutic protocol
III To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis
IV To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls using constitutional deoxyribonucleic acid DNA and ribonucleic acid RNA from the cases and controls
V To explore the role and nature of gene-environment interaction in the development of key adverse events
OUTLINE
DNA and RNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications
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 |
|---|---|---|---|
| UG1CA189958 | NIH | CTEP | httpsreporternihgovquickSearchUG1CA189958 |
| COG-ALTE03N1 | None | None | None |
| CDR0000360708 | None | None | None |
| ALTE03N1 | OTHER | None | None |
| ALTE03N1 | OTHER | None | None |
| U10CA180886 | NIH | None | None |
| U10CA095861 | NIH | None | None |
| UG1CA189955 | NIH | None | None |