Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00340353

Collaborator

(none)

99,999

Enrollment

Location

84.2

Duration (Months)

1188

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alveolar Soft Part Sarcoma Sarcoma

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 Design

Study Type:

Observational

Anticipated Enrollment :

99999 participants

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 :

Apr 7, 2005

Study Completion Date :

Apr 12, 2012

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.