Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research

Descriptive Information
Brief Title ^†	Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research
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
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 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.
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 and/or 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 Phase	N/A
Study Type ^†	Observational
Study Design ^†	N/A
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Alveolar Soft Part Sarcoma Sarcoma
Intervention ^†
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†
Estimated Enrollment ^†	99999
Start Date ^†	April 2005
Completion Date	April 2012
Primary Completion Date
Eligibility Criteria ^†	INCLUSION CRITERIA: 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.
Gender	Both
Ages	4 Years - N/A
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts ^††	, , , ,
Location Countries ^†	United States,
Administrative Information
NCT ID ^†	NCT00340353
Organization ID	999905138
Secondary IDs ^††	05-C-N138
Responsible Party	,
Study Sponsor ^†	National Cancer Institute (NCI)
Collaborators ^††
Investigators ^†	Principal Investigator: Michael Dean, Ph.D., National Cancer Institute (NCI)
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	April 2012
First Received Date ^†	June 19, 2006
Last Updated Date	April 13, 2012

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.