Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research

June 30, 2017 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

99999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI), 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 7, 2005

Study Completion

April 12, 2012

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

April 12, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999905138
  • 05-C-N138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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