Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003793
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
1999-11-01
Brief Title:
Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Clinical and Biological Predictors of Therapy-Related Leukemia
Status:
COMPLETED
Status Verified Date:
2014-08
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 soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia
PURPOSE Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma
PURPOSE Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma
Detailed Description:
OBJECTIVES
Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia t-MDSAML prior to initiation of high-dose chemotherapy for sarcoma
Identify patients who are at increased risk of t-MDSAML during or after therapy
OUTLINE Blood is collected from patients at diagnosis preferably before chemotherapy or transfusion at end of therapy and at 6 months 1 year 2 years and 3 years after therapy
Blood specimens are examined by clonality analysis HUMARA variant cell frequency glycophorin A assay GST NAT2CYP1A1 genotyping microsatellite instability and ras mutation detection single strand conformation polymorphism and sequencing of mutant alleles
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
PROJECTED ACCRUAL A total of 321 patients will be accrued for this study within 4 years
Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia t-MDSAML prior to initiation of high-dose chemotherapy for sarcoma
Identify patients who are at increased risk of t-MDSAML during or after therapy
OUTLINE Blood is collected from patients at diagnosis preferably before chemotherapy or transfusion at end of therapy and at 6 months 1 year 2 years and 3 years after therapy
Blood specimens are examined by clonality analysis HUMARA variant cell frequency glycophorin A assay GST NAT2CYP1A1 genotyping microsatellite instability and ras mutation detection single strand conformation polymorphism and sequencing of mutant alleles
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
PROJECTED ACCRUAL A total of 321 patients will be accrued for this study within 4 years
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 |
|---|---|---|---|
| CDR0000066936 | OTHER | Clinical Trialsgov | None |
| COG-AB9804 | OTHER | None | None |
| CCG-B9804 | OTHER | None | None |