## Protocol Section
### Identification Module
**NCT ID:** NCT06436846

**Brief Title:** Genomic Risk in Retroperitoneal Sarcoma

**Official Title:** Characterization of the Genomic Risk Underlying Retroperitoneal Liposarcoma

#### Organization Study ID Info
**ID:** 21-8008
#### Organization
**Class:** OTHER
**Full Name:** Fox Chase Cancer Center
### Status Module
#### Completion Date
**Date:** 2027-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-03-07

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fox Chase Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Retroperitoneal Liposarcoma

- Soft Tissue Sarcoma

### Design Module

#### Bio Spec

**Description:** Samples of retroperitoneal fat (x4), subcutaneous fat (x1), primary tumor samples (x3) - all collected during surgery for tumor.

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Biospecimen sample collection during standard-of-care surgery

**Label:** Cohort 1

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cohort 1

**Description:** 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.

**Name:** Biospecimen sample collection during standard-of-care surgery

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** MDM2 amplification of primary tumors and fat samples will be tested by immunohistochemistry and/or fluorescence in situ hybridization.

**Measure:** Presence of MDM2 amplification in "normal" retroperitoneal fat

**Time Frame:** Through study completion, an average of 3 years

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients (age 18 years or older) with retroperitoneal tumors suspicious for liposarcoma.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** anthony.villano@fccc.edu

**Name:** Anthony Villano, MD

**Phone:** 215-728-3686

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Philadelphia

**Contacts:**

***Contact 1:***

- **Email:** anthony.villano@fccc.edu

- **Name:** Anthony Villano, MD

- **Phone:** 215-728-3686

- **Role:** CONTACT

***Contact 2:***

- **Name:** Margaret vonMehren, MD

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Andres Correa, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Jeffrey Farma, MD, FACS

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Stephanie Greco, MD, FACS

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Alexander Kutikov, MD, FACS

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Sanjay Reddy, MD, FACS

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** Lori Rink, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 9:***

- **Name:** Marc Smaldone, MD, MSHP, FACS

- **Role:** SUB_INVESTIGATOR

***Contact 10:***

- **Name:** Robert Uzzo, MD, MBA, FACS

- **Role:** SUB_INVESTIGATOR

***Contact 11:***

- **Name:** Rosalia Viterbo, MD, FACS

- **Role:** SUB_INVESTIGATOR

***Contact 12:***

- **Name:** Shuanzeng Wei, MD, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 13:***

- **Name:** Johnathan Whetstine, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 14:***

- **Name:** Margaret von Mehren, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Fox Chase Cancer Center

**State:** Pennsylvania

**Status:** RECRUITING

**Zip:** 19111

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000018205

- Term: Neoplasms, Adipose Tissue

- ID: D000000008

- Term: Abdominal Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15327

- Name: Sarcoma

- Relevance: HIGH

- As Found: Sarcoma

- ID: M11080

- Name: Liposarcoma

- Relevance: HIGH

- As Found: Liposarcoma

- ID: M15020

- Name: Retroperitoneal Neoplasms

- Relevance: HIGH

- As Found: Retroperitoneal Liposarcoma

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20351

- Name: Neoplasms, Adipose Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M7

- Name: Abdominal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: T5284

- Name: Soft Tissue Sarcoma

- Relevance: HIGH

- As Found: Soft Tissue Sarcoma

- ID: T3479

- Name: Liposarcoma

- Relevance: HIGH

- As Found: Liposarcoma

- ID: T4986

- Name: Retroperitoneal Liposarcoma

- Relevance: HIGH

- As Found: Retroperitoneal Liposarcoma

### Condition Browse Module - Meshes

- ID: D000012509

- Term: Sarcoma

- ID: D000008080

- Term: Liposarcoma

- ID: D000012186

- Term: Retroperitoneal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
