Genomic Risk in Retroperitoneal Sarcoma

May 28, 2024 updated by: Fox Chase Cancer Center

Characterization of the Genomic Risk Underlying Retroperitoneal Liposarcoma

The protocol intends to explore the biology which may underlie recurrences of retroperitoneal liposarcoma. Surgery remains the only curative intent intervention for this disease. Often, tumors recur in locations within the retroperitoneum remote from the original primary tumor. This study hypothesizes that normal appearing retroperitoneal fat actually harbors underlying genetic changes which predispose to development of future liposarcoma. To accomplish this goal, retroperitoneal fat is sampled from quadrants within and remote from the primary tumor and is subsequently subjected to genetic analyses looking for such predisposing factors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

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

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Contact:
        • Sub-Investigator:
          • Margaret vonMehren, MD
        • Sub-Investigator:
          • Andres Correa, MD
        • Sub-Investigator:
          • Jeffrey Farma, MD, FACS
        • Sub-Investigator:
          • Stephanie Greco, MD, FACS
        • Sub-Investigator:
          • Alexander Kutikov, MD, FACS
        • Sub-Investigator:
          • Sanjay Reddy, MD, FACS
        • Sub-Investigator:
          • Lori Rink, PhD
        • Sub-Investigator:
          • Marc Smaldone, MD, MSHP, FACS
        • Sub-Investigator:
          • Robert Uzzo, MD, MBA, FACS
        • Sub-Investigator:
          • Rosalia Viterbo, MD, FACS
        • Sub-Investigator:
          • Shuanzeng Wei, MD, PhD
        • Sub-Investigator:
          • Johnathan Whetstine, PhD
        • Sub-Investigator:
          • Margaret von Mehren, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult patients (age 18 years or older) with retroperitoneal tumors suspicious for liposarcoma.

Description

Inclusion Criteria:

  • Adult patients (age ≥18 years).
  • Histologically confirmed retroperitoneal liposarcoma via preoperative biopsy, or cross-sectional imaging suspicious for liposarcoma with planned surgical resection
  • Will be undergoing surgical resection for treatment of primary or recurrent disease
  • Have provided informed consent to participate in this study

Exclusion Criteria:

• Prior surgical anatomy which makes sampling of remote areas of the retroperitoneum technically impossible or clinically undesirable for safety reasons

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
Cohort 1
The entire study is a singular cohort of patients with retroperitoneal liposarcoma (index or recurrent) who undergo surgical resection of their tumor.
Other: Biospecimen sample collection during standard-of-care surgery
Patients in this observational study are undergoing planned surgical resection of their retroperitoneal sarcoma as prescribed by their primary surgeon and treatment team. In addition to removal of the primary tumor, surgeons remove 4 samples of retroperitoneal fat and a sample of subcutaneous fat for further study at the time of the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of MDM2 amplification in "normal" retroperitoneal fat
Time Frame: Through study completion, an average of 3 years
MDM2 amplification of primary tumors and fat samples will be tested by immunohistochemistry and/or fluorescence in situ hybridization.
Through study completion, an average of 3 years

Collaborators and Investigators

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

Sponsor

Fox Chase Cancer Center

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)

March 7, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-8008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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