Genomic Risk in Retroperitoneal Sarcoma

Recruiting

• Conditions: Soft Tissue Sarcoma; Retroperitoneal Liposarcoma
• Interventions: Other: Biospecimen sample collection during standard-of-care surgery

• Registration Number: NCT06436846
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-07
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31
• Primary Completion: 2027-06-30
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Biospecimen sample collection during standard-of-care surgery	The entire study is a singular cohort of patients with retroperitoneal liposarcoma (index or recurrent) who undergo surgical resection of their tumor.

Primary Outcome Measures

Name	Time	Method
Presence of MDM2 amplification in "normal" retroperitoneal fat	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.

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States