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Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma

This study is currently recruiting participants.
Verified September 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00579566
First Posted: December 24, 2007
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  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 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.

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • establish and maintain a specimen bank and sarcoma cell line resource [ Time Frame: 2 years ]
    for laboratory-based studies on the causes, prevention, diagnosis and treatment of human soft tissue sarcoma


Secondary Outcome Measures:
  • identify new rational therapeutic targets [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Tissue, Blood

Estimated Enrollment: 3000
Actual Study Start Date: June 2002
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (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 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579566


Contacts
Contact: Samuel Singer, M.D. 212-639-2940

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Samuel Singer, MD    212-639-2940      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Samuel Singer, MD    212-639-2164      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Samuel Singer, MD    212-639-2940      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Samuel Singer, MD    212-639-2940      
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.         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Singer Singer, M.D. Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00579566     History of Changes
Other Study ID Numbers: 02-060
First Submitted: December 19, 2007
First Posted: December 24, 2007
Last Update Posted: September 19, 2017
Last Verified: September 2017

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