Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma - Full Text View

Purpose

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 biochemical and molecular analysis of your tissue. We will only use extra tissue left over after all needed testing has been done. 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.

Condition	Intervention
Sarcoma	Other: Specimen protocol

MedlinePlus related topics:

Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

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

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Analyze NMR biochemical and molecular patterns from oligonucleotide, SNP and CGH arrays to identify markers that can provide an objective measure of sarcoma differentiation, cellularity, proliferation, necrosis and apoptosis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the variability of NMR biochemical and molecular profiles from oligonucleotide, SNP and CGH arrays within different regions of the primary sarcoma. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Tissue, Blood

Estimated Enrollment:	3000
Study Start Date:	June 2002
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Sarcoma patients undergoing core biopsy, incisional biopsy or definitive surgical resection for soft tissue masses of extremity, trunk or retroperitoneum	Other: Specimen protocol The research specimen will be obtained from the residual specimen that would otherwise be discarded per usual hospital procedure.

Detailed Description:

In this protocol, we plan to identify specific markers from nuclear magnetic resonance (NMR)biochemical and molecular genetic analysis that predict clinical outcome and responsiveness to therapy in patients with soft tissue sarcoma. Although most sarcomas rarely present diagnostic dilemmas because each has consistent morphologic and cytogenetic features that can readily be identified, it is not possible with conventional methods to predict what the clinical outcome will be for each individual patient, or how a given tumor will respond to neoadjuvant therapy. Thus,new methods for assessing the potential of these tumors to recur or metastasize and respond to therapy will result in real benefits for patients with these sarcomas.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients seen or referred by Memorial Sloan-Kettering Cancer physicians

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579566

Contacts


Contact: Samuel Singer, M.D.		singers@mskcc.org

Locations


United States, New York
	Memorial Sloan-Kettering Cancer Center	Recruiting
	new York, New York, United States, 10065
	Contact: Samuel Singer, M.D. singers@mskc..org
	Principal Investigator: Samuel Singer, M.D.

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators


Principal Investigator:	Singer Singer, M.D.	Memorial Sloan-Kettering Cancer Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Samuel Singer, M.D. )
Study ID Numbers:	02-060
First Received:	December 19, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00579566
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Biochemical Determinants

Molecular Determinants

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue

Malignant mesenchymal tumor

Sarcoma

Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00579566