Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339898
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-06-19
Brief Title:
Prognostic Value of a Positive RT-PCR Test in Patients With Ewing Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prospective Evaluation of the Prognostic Relevance of PCR Positivity in Blood and Bone Marrow in Non-Metastatic Ewings Sarcoma
Status:
COMPLETED
Status Verified Date:
2015-01-13
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 study will determine whether the results of a test called reverse transcriptase-polymerase chain reaction RT-PCR correlate with clinical outcomes in patients with Ewing sarcoma and if they can be used to help identify patients at high risk for metastasis spread of the cancer beyond the original site
This is a companion study to another NCI trial AEWS0031 which is examining the effectiveness of an intensified chemotherapy regimen for patients with Ewing sarcoma The primary purposes of AEWS0031 are to determine 1 if chemotherapy given every 2 weeks can cure more patients with Ewing sarcoma and similar tumors than chemotherapy given every 3 weeks and 2 if certain biological characteristics of these tumors can predict how well the chemotherapy will work
Many but not all patients with Ewing sarcoma that has not metastasized can be cured with standard radiation surgery and chemotherapy treatment Most patients whose tumors have spread however are not cured with standard treatment A goal of future therapy is to identify patients at highest risk for metastasis so that they can be given more intensive therapy and conversely patients at lower risk of relapse can receive less toxic treatment
Patients enrolled in AEWS0031 are eligible for this companion study No additional procedures re required RT-PCR testing will be performed on blood and bone marrow samples collected for AEWS0031
This is a companion study to another NCI trial AEWS0031 which is examining the effectiveness of an intensified chemotherapy regimen for patients with Ewing sarcoma The primary purposes of AEWS0031 are to determine 1 if chemotherapy given every 2 weeks can cure more patients with Ewing sarcoma and similar tumors than chemotherapy given every 3 weeks and 2 if certain biological characteristics of these tumors can predict how well the chemotherapy will work
Many but not all patients with Ewing sarcoma that has not metastasized can be cured with standard radiation surgery and chemotherapy treatment Most patients whose tumors have spread however are not cured with standard treatment A goal of future therapy is to identify patients at highest risk for metastasis so that they can be given more intensive therapy and conversely patients at lower risk of relapse can receive less toxic treatment
Patients enrolled in AEWS0031 are eligible for this companion study No additional procedures re required RT-PCR testing will be performed on blood and bone marrow samples collected for AEWS0031
Detailed Description:
BACKGROUND Clinical evidence for metastatic disease at the time of diagnosis is an indicator of poor prognosis in Ewings sarcoma Patients with non-metastatic disease at presentation are thought to have a better prognosis than those with metastatic disease Unfortunately patients who appear non-metastatic at presentation may relapse after initiating or completing standard therapy for Ewings sarcoma Evidence of metastatic disease may be determined by radiographic studies and biopsy of potential sites of disease It is possible to identify submicroscopic Ewings sarcoma cells in blood and bone marrow yet the prognostic value of this finding is unclear
OBJECTIVES To determine the incidence of RT PCR positivity in the blood and bone marrow of patients enrolled on COG AEWS0031 and to correlate the clinical outcome with RT PCR positivity
ELIGIBILITY Concurrent enrollment on COG AEWS0031
DESIGN This is a Companion Biology Study enrolling approximately 500 patients All specimens will be evaluated for translocations it is anticipated that approximately 30 of specimens will have RT PCR positivity Specimens are collected at the time of diagnosis prior to cycle 2 chemotherapy prior to initiation of local control and at the end of therapyfollow up Batched specimens are provided to the NIH by the Cooperative Human Tissue Network CHTN Following the completion of the COG trial and appropriate follow up periods RT PCR positivity will be compared with clinical outcome to determine prognostic value
OBJECTIVES To determine the incidence of RT PCR positivity in the blood and bone marrow of patients enrolled on COG AEWS0031 and to correlate the clinical outcome with RT PCR positivity
ELIGIBILITY Concurrent enrollment on COG AEWS0031
DESIGN This is a Companion Biology Study enrolling approximately 500 patients All specimens will be evaluated for translocations it is anticipated that approximately 30 of specimens will have RT PCR positivity Specimens are collected at the time of diagnosis prior to cycle 2 chemotherapy prior to initiation of local control and at the end of therapyfollow up Batched specimens are provided to the NIH by the Cooperative Human Tissue Network CHTN Following the completion of the COG trial and appropriate follow up periods RT PCR positivity will be compared with clinical outcome to determine prognostic value
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 |
|---|---|---|---|
| 04-C-N135 | None | None | None |