Recruiting

Genomic Risk

Sponsor:

Fox Chase Cancer Center

Code:

NCT06436846

Conditions

Retroperitoneal Liposarcoma

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Biospecimen sample collection during standard-of-care surgery

Study Details

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.

Conditions

Retroperitoneal Liposarcoma

Soft Tissue Sarcoma

Study ID

NCT06436846

Start date

Mar 7, 2022

Status verified date

May, 2024

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

The entire study is a singular cohort of patients with retroperitoneal liposarcoma (index or recurrent) who undergo surgical resection of their tumor.

Interventions

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.

Primary outcome measure

  • Presence of MDM2 amplification in "normal" retroperitoneal fat [ Time Frame: Through study completion, an average of 3 years ]

Central Contacts and Locations

Central contacts

Anthony Villano, MD

215-728-3686anthony.villano@fccc.edu

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Anthony Villano, MD

215-728-3686anthony.villano@fccc.edu

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

May 31, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2024-05-31.