Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340353
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Procurement of Blood and Tissue From Patients With Primary and Metastatic Alveolar Soft Part Sarcoma and Blood From Healthy Controls for In Vitro and In Vivo Model Development
Status:
COMPLETED
Status Verified Date:
2012-04-12
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:
Background
Alveolar soft part sarcoma ASPS is a rare tumor
ASPS is resistant to chemotherapy and radiation
ASPS is characterized by slow growth
Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic studies or biological investigations
Primary Objectives
Acquisition of blood and tissue from patients with ASPS
Acquisition of blood from healthy controls for comparison with blood from patients with ASPS These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046
Eligibility
Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease
Design
Patients with Alveolar Soft Part Sarcoma ASPS will be eligible for this study Biopsy tissue will be obtained as an additional sample at the time of a medically indicated procedure Blood sample may be collected at initial visit and follow-up visits Specific risks will be described in a separate consent to be obtained at the time of the biopsy Tumor samples and blood samples will be processed andor stored for use in research efforts in the laboratory of Dr David Vistica National Cancer Institute Frederick MD Additionally blood samples will be obtained from healthy volunteers for comparison to patients with ASPS These control samples will be obtained from the National Cancer Institute at Frederick Protocol OH99-C-N046
Alveolar soft part sarcoma ASPS is a rare tumor
ASPS is resistant to chemotherapy and radiation
ASPS is characterized by slow growth
Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic studies or biological investigations
Primary Objectives
Acquisition of blood and tissue from patients with ASPS
Acquisition of blood from healthy controls for comparison with blood from patients with ASPS These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046
Eligibility
Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease
Design
Patients with Alveolar Soft Part Sarcoma ASPS will be eligible for this study Biopsy tissue will be obtained as an additional sample at the time of a medically indicated procedure Blood sample may be collected at initial visit and follow-up visits Specific risks will be described in a separate consent to be obtained at the time of the biopsy Tumor samples and blood samples will be processed andor stored for use in research efforts in the laboratory of Dr David Vistica National Cancer Institute Frederick MD Additionally blood samples will be obtained from healthy volunteers for comparison to patients with ASPS These control samples will be obtained from the National Cancer Institute at Frederick Protocol OH99-C-N046
Detailed Description:
Background
Alveolar soft part sarcoma ASPS is a rare tumor
ASPS is resistant to chemotherapy and radiation
ASPS is characterized by slow growth
Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic studies or biological investigations were generated under this protocol
Additional models are needed to represent the heterogeneity of this disease
Primary Objectives
Acquisition of blood and tissue from patients with ASPS
Acquisition of blood from healthy controls for comparison with blood from patients with ASPS These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046
Eligibility
Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease
Design
Patients with Alveolar Soft Part Sarcoma ASPS will be eligible for this study Biopsy tissue will be obtained as an additional sample at the time of a medically indicated procedure Blood sample may be collected at initial visit and follow-up visits Specific risks will be described in a separate consent to be obtained at the time of the biopsy Tumor samples and blood samples will be processed andor stored for use in research efforts in the laboratory of Dr Robert Shoemaker National Cancer Institute Frederick MD Additionally blood samples will be obtained from healthy volunteers for comparison to patients with ASPS These control samples will be obtained from the National Cancer Institute at Frederick Protocol OH99-C-N046
Alveolar soft part sarcoma ASPS is a rare tumor
ASPS is resistant to chemotherapy and radiation
ASPS is characterized by slow growth
Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic studies or biological investigations were generated under this protocol
Additional models are needed to represent the heterogeneity of this disease
Primary Objectives
Acquisition of blood and tissue from patients with ASPS
Acquisition of blood from healthy controls for comparison with blood from patients with ASPS These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046
Eligibility
Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease
Design
Patients with Alveolar Soft Part Sarcoma ASPS will be eligible for this study Biopsy tissue will be obtained as an additional sample at the time of a medically indicated procedure Blood sample may be collected at initial visit and follow-up visits Specific risks will be described in a separate consent to be obtained at the time of the biopsy Tumor samples and blood samples will be processed andor stored for use in research efforts in the laboratory of Dr Robert Shoemaker National Cancer Institute Frederick MD Additionally blood samples will be obtained from healthy volunteers for comparison to patients with ASPS These control samples will be obtained from the National Cancer Institute at Frederick Protocol OH99-C-N046
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 |
|---|---|---|---|
| 05-C-N138 | None | None | None |