Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research

NCT ID: NCT00340353

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-07

Study Completion Date

2012-04-12

Brief Summary

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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

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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.

Conditions

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Alveolar Soft Part Sarcoma Sarcoma

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Principal Investigators

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Michael Dean, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 14886902 (View on PubMed)

Other Identifiers

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05-C-N138

Identifier Type: -

Identifier Source: secondary_id

999905138

Identifier Type: -

Identifier Source: org_study_id

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