Recruiting

NCT Number: NCT06436846

Genomic Risk in Retroperitoneal Sarcoma

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.

Recruiting

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Key information

Conditions

Retroperitoneal Liposarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location status: Recruiting

Location contact

Alexander Kutikov, MD, FACS

SUB_INVESTIGATOR

Andres Correa, MD

SUB_INVESTIGATOR

Anthony Villano, MD

CONTACT

[email protected]

215-728-3686

Jeffrey Farma, MD, FACS

SUB_INVESTIGATOR

Johnathan Whetstine, PhD

SUB_INVESTIGATOR

Lori Rink, PhD

SUB_INVESTIGATOR

Marc Smaldone, MD, MSHP, FACS

SUB_INVESTIGATOR

Margaret von Mehren, MD

SUB_INVESTIGATOR

Margaret vonMehren, MD

SUB_INVESTIGATOR

Robert Uzzo, MD, MBA, FACS

SUB_INVESTIGATOR

Rosalia Viterbo, MD, FACS

SUB_INVESTIGATOR

Sanjay Reddy, MD, FACS

SUB_INVESTIGATOR

Shuanzeng Wei, MD, PhD

SUB_INVESTIGATOR

Stephanie Greco, MD, FACS

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen sample collection during standard-of-care surgery

Other

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 outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Villano, MD

CONTACT

[email protected]

215-728-3686

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Registry information

Official study title

Characterization of the Genomic Risk Underlying Retroperitoneal Liposarcoma

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2027
First posted: May 31, 2024
Registry last updated: May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting