Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048984
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2002-11-12
Brief Title:
Diagnostic Study of Tumor Characteristics in Patients With Ewings Sarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Groupwide Biology and Banking Study for Ewing Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Diagnostic trial to study genetic differences in patients who have Ewings sarcoma Genetic testing may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy
Detailed Description:
PRIMARY OBJECTIVES
I To develop a mechanism to collect and distribute tumor specimens to various investigators and a system to prioritize and develop quality-control measures for central data reporting of studies undertaken
II To determine the prognostic significance of translocation subtype in Ewing sarcoma to determine the prognostic significance of translocation negative Ewing sarcoma
III To determine the prognostic significance of MRD detection in bone marrow specimens by RT-PCR determination of EWS-ETS fusion genes
IV To determine whether serum levels of IGF1 IGFBP3 are of significance in the outcome of patients with Ewing sarcoma
V To determine whether RNA expression profiles performed on diagnostic specimens will allow for the identification of newer prognostic categories and potentially new molecular targets for treatment in Ewing sarcoma
VI To identify new treatment targets for therapy Further testing of these potential targets will be carried out in hopes of expediting translation of these findings to the clinic
VII To establish a bank of Ewing sarcoma xenografts in SCIDBeige mice VIII To establish clinical proteomics as a resource for investigations of altered signaling molecules in the pathogenesis of Ewing sarcoma
OUTLINE This is a multicenter study
Patients undergo various specimen collections including bone marrow aspirate paraffin-embedded blocks of tumor tissue or slides of tumor tissue and blood specimens These specimens are collected before during and after any chemotherapy regimens during follow-up and at time of recurrence Translocation studies are performed on specimens to identify fusion genes specifically EWS-ETS Serum IGF1 and IFGBP3 levels are determined Bone marrow is assessed for minimal residual disease using reverse-transcriptase polymerase chain reaction
I To develop a mechanism to collect and distribute tumor specimens to various investigators and a system to prioritize and develop quality-control measures for central data reporting of studies undertaken
II To determine the prognostic significance of translocation subtype in Ewing sarcoma to determine the prognostic significance of translocation negative Ewing sarcoma
III To determine the prognostic significance of MRD detection in bone marrow specimens by RT-PCR determination of EWS-ETS fusion genes
IV To determine whether serum levels of IGF1 IGFBP3 are of significance in the outcome of patients with Ewing sarcoma
V To determine whether RNA expression profiles performed on diagnostic specimens will allow for the identification of newer prognostic categories and potentially new molecular targets for treatment in Ewing sarcoma
VI To identify new treatment targets for therapy Further testing of these potential targets will be carried out in hopes of expediting translation of these findings to the clinic
VII To establish a bank of Ewing sarcoma xenografts in SCIDBeige mice VIII To establish clinical proteomics as a resource for investigations of altered signaling molecules in the pathogenesis of Ewing sarcoma
OUTLINE This is a multicenter study
Patients undergo various specimen collections including bone marrow aspirate paraffin-embedded blocks of tumor tissue or slides of tumor tissue and blood specimens These specimens are collected before during and after any chemotherapy regimens during follow-up and at time of recurrence Translocation studies are performed on specimens to identify fusion genes specifically EWS-ETS Serum IGF1 and IFGBP3 levels are determined Bone marrow is assessed for minimal residual disease using reverse-transcriptase polymerase chain reaction
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 |
|---|---|---|---|
| NCI-2012-02494 | REGISTRY | None | None |
| CDR0000257115 | OTHER | None | None |
| COG-AEWS02B1 | OTHER | None | None |
| NCI-03-C-0216 | OTHER | None | None |
| U10CA098543 | NIH | NCI | httpsreporternihgovquickSearchU10CA098543 |