Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma |
- 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 ]
- 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
Tissue, Blood
| Estimated Enrollment: | 3000 |
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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 |
Patients seen or referred by Memorial Sloan-Kettering Cancer physicians
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| Contact: Samuel Singer, M.D. | 212-639-2940 |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| new York, New York, United States, 10065 | |
| Contact: Samuel Singer, M.D. 212-639-2940 | |
| Principal Investigator: Samuel Singer, M.D. | |
| Principal Investigator: | Singer Singer, M.D. | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00579566 History of Changes |
| Other Study ID Numbers: | 02-060 |
| Study First Received: | December 19, 2007 |
| Last Updated: | October 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Biochemical Determinants Molecular Determinants |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on October 17, 2012
