Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma

July 27, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Samuel Singer, MD
  • Phone Number: 212-639-2940

Study Contact Backup

  • Name: Aimee Crago, MD, PhD

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up)
        • Contact:
          • Samuel Singer, MD
          • Phone Number: 212-639-2940
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Consent and Followup)
        • Contact:
          • Samuel Singer, MD
          • Phone Number: 212-639-2940
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Consent and Follow up)
        • Contact:
          • Sam Singer, MD
          • Phone Number: 212-639-2940
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack (Consent and Follow-Up)
        • Contact:
          • Samuel Singer, MD
          • Phone Number: 212-639-2940
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Consent and Followup)
        • Contact:
          • Samuel Singer, MD
          • Phone Number: 212-639-2940
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Samuel Singer, M.D.
          • Phone Number: 212-639-2940
        • Principal Investigator:
          • Samuel Singer, M.D.
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Consent and Followup)
        • Contact:
          • Sam Singer, MD
          • Phone Number: 212-639-2940

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients seen or referred by Memorial Sloan-Kettering Cancer physicians

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
identify new rational therapeutic targets
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Singer Singer, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2002

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimated)

December 24, 2007

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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