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Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research

Primary Purpose

Alveolar Soft Part Sarcoma, Sarcoma

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Alveolar Soft Part Sarcoma focused on measuring Gene Expression, Drug Sensitivity, TFE3, ASPL-TFE3, NOD-SCID Mice, Sarcoma, Alveolar Soft Part Sarcoma, ASPS

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI), 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 19, 2006
Last Updated
June 30, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00340353
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
Study Type
Observational

2. Study Status

Record Verification Date
April 12, 2012
Overall Recruitment Status
Completed
Study Start Date
April 7, 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 12, 2012 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Soft Part Sarcoma, Sarcoma
Keywords
Gene Expression, Drug Sensitivity, TFE3, ASPL-TFE3, NOD-SCID Mice, Sarcoma, Alveolar Soft Part Sarcoma, ASPS

7. Study Design

Enrollment
99999 (Anticipated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dean, Ph.D.
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute (NCI), 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14886902
Citation
CHRISTOPHERSON WM, FOOTE FW Jr, STEWART FW. Alveolar soft-part sarcomas; structurally characteristic tumors of uncertain histogenesis. Cancer. 1952 Jan;5(1):100-11. doi: 10.1002/1097-0142(195201)5:13.0.co;2-k. No abstract available.
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Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research

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