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NCT06436846 Clinical Trial

Genomic Risk in Retroperitoneal Sarcoma

Soft Tissue Sarcoma Clinical Trial

Official title:
Characterization of the Genomic Risk Underlying Retroperitoneal Liposarcoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06436846
Other study ID # 21-8008
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 7, 2022
Est. completion date August 1, 2027

Study information
Verified date May 2024
Source Fox Chase Cancer Center
Contact Anthony Villano, MD
Phone 215-728-3686
Email anthony.villano@fccc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date August 1, 2027
Est. primary completion date June 30, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Fox Chase Cancer Center Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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