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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00340353 |
Purpose
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 and/or 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.
| Condition |
|---|
|
Alveolar Soft Part Sarcoma Sarcoma |
| Study Type: | Observational |
| 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 |
| Study Start Date: | April 2005 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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 and/or 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.
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease.
EXCLUSION CRITERIA:
None.
Contacts and Locations| Contact: David T. Vistica, Ph.D. | (301) 846-5385 | dv15e@nih.gov |
| United States, Maryland | |
| NCI Frederick Cancer Research Center | Recruiting |
| Frederick, Maryland, United States, 21702-1201 | |
More Information
| Study ID Numbers: | 999905138, 05-C-N138 |
| Study First Received: | June 19, 2006 |
| Last Updated: | August 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00340353 History of Changes |
| Health Authority: | United States: Federal Government |
|
Gene Expression Drug Sensitivity TFE3 ASPL-TFE3 |
NOD-SCID Mice Sarcoma Alveolar Soft Part Sarcoma ASPS |
|
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Sarcoma |
Sarcoma, Alveolar Soft Part Healthy Alveolar Soft Part Sarcoma |
|
Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neoplasms |
Neoplasms by Histologic Type Sarcoma Sarcoma, Alveolar Soft Part |
