Genomic Risk in Retroperitoneal Sarcoma

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: Soft Tissue Sarcoma; Retroperitoneal Liposarcoma
• Intervention / Treatment: Other: Biospecimen sample collection during standard-of-care surgery

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Anthony Villano, MD; Phone Number: 215-728-3686; Email: anthony.villano@fccc.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
      • Contact: Anthony Villano, MD; Phone Number: 215-728-3686; Email: anthony.villano@fccc.edu
      • 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

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

How is the study designed?

Number of groups / cohorts

1

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	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

• Sponsor: Fox Chase Cancer Center

Study record dates

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: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Abdominal Neoplasms; Neoplasms, Adipose Tissue; Sarcoma; Liposarcoma; Retroperitoneal Neoplasms
• 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