NCT00340353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99,999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2012

Completed
Last Updated

July 2, 2017

Status Verified

April 12, 2012

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Gene ExpressionDrug SensitivityTFE3ASPL-TFE3NOD-SCID MiceSarcomaAlveolar Soft Part SarcomaASPS

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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.

    PMID: 14886902BACKGROUND

MeSH Terms

Conditions

Sarcoma, Alveolar Soft PartSarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Michael Dean, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

April 7, 2005

Study Completion

April 12, 2012

Last Updated

July 2, 2017

Record last verified: 2012-04-12

Locations