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NCT00579566 Clinical Trial

Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma

Sarcoma Clinical Trial

Official title:
Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00579566
Other study ID # 02-060
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2002
Est. completion date June 2025

Study information
Verified date July 2023
Source Memorial Sloan Kettering Cancer Center
Contact Samuel Singer, MD
Phone 212-639-2940
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to study normal and sarcoma cells. To study these cells we need to have human tissue. You will be having or have already had a procedure to remove tissue. We would like to use some of this tissue. We will use it for laboratory studies on the diagnosis,behavior and treatment of sarcoma. We will perform an extensive analysis of your samples. We will only use extra tissue left over after all needed testing has been done or remove an additional small amount of tissue if you are having a biopsy. We will also take blood samples before and/or after your procedure to measure biochemical factors that may help us predict the behavior of sarcoma.

Description:

In this protocol, we plan to identify specific markers from biochemical, proteomic, epigenetic and molecular genetic analyses that predict clinical outcome, responsiveness to therapy and might serve as promising therapeutic targets in patients with soft tissue sarcoma.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients with known or suspected sarcoma who will have or have had tissue removed for therapeutic or diagnostic purposes. - Patients will be entered without preference for any particular racial/ethnic group or gender. - Patients may have received prior hormonal therapy, cytotoxic chemotherapy, irradiation, immunotherapy or surgical therapy. - Tissue specimens must be large enough in quantity to allow routine pathologic analysis, with the research laboratory specimen removed from the residual specimen, which would otherwise be discarded. Optimal tissue amounts for snap freeze: Core biopsy - 2 tissue cores Incisional biopsy- 0.5 to 1.5 grams Resected sarcoma specimen- 1.0 to 50 grams depending on size of specimen Normal fat or muscle tissue - 0.5 to 4.0 grams (if available from resected sarcoma specimen) Optimal tissue amounts for RNA later Core biopsy - 2 tissue cores Incisional biopsy- 30 mg (three 3 x 3 x 3 mm cubes) Resected sarcoma specimen - 30 mg (three 3 x 3 x 3 mm cubes) Normal fat or muscle tissue - 30 mg (three 3 x 3 x 3 mm cube Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Specimen protocol
The research specimen will be obtained from the residual specimen that would otherwise be discarded per usual hospital procedure.

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack (Consent and Follow-Up) Commack New York
United States Memorial Sloan Kettering Westchester (Consent and Followup) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent and Followup) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent and Follow up) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (Consent and Followup) Rockville Centre New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary establish and maintain a specimen bank and sarcoma cell line resource for laboratory-based studies on the causes, prevention, diagnosis and treatment of human soft tissue sarcoma 2 years
Secondary identify new rational therapeutic targets 2 years
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