Retroperitoneal LiposarcomaNCT06436846
Genomic Risk in Retroperitoneal Sarcoma
An observational study of Retroperitoneal Liposarcoma and Soft Tissue Sarcoma, run by Fox Chase Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retroperitoneal Liposarcoma, Soft Tissue Sarcoma
- What is being tested?
- Biospecimen sample collection during standard-of-care surgery
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 1 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (age 18 years or older) with retroperitoneal tumors suspicious for liposarcoma.
Who may be able to join
- 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
Who cannot join
- Prior surgical anatomy which makes sampling of remote areas of the retroperitoneum technically impossible or clinically undesirable for safety reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Anthony Villano, MD, 215-728-3686, anthony.villano@fccc.edu
Margaret vonMehren, MD
About this study
Official title: 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.
- Conditions
- Retroperitoneal Liposarcoma, Soft Tissue Sarcoma
- Being tested
- Biospecimen sample collection during standard-of-care surgery
- Medical subject headings
- Retroperitoneal liposarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen sample collection during standard-of-care surgeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | The entire study is a singular cohort of patients with retroperitoneal liposarcoma (index or recurrent) who undergo surgical resection of their tumor. Receives: Other: Biospecimen sample collection during standard-of-care surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start7 Mar 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retroperitoneal LiposarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436846
- Sponsor's protocol ID
- 21-8008
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No