Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

This is a pilot study gathering and using samples and data from patients with gastrointestinal peritoneal carcinomatosis. Participants will be asked for permission to provide blood and ascites/peritoneal wash fluid, tumor samples during their planned surgical procedure.

Study Overview

• Status: Recruiting
• Conditions: Peritoneal Carcinomatosis; Gastrointestinal Peritoneal Carcinomatosis
• Intervention / Treatment: Other: Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chao Family Comprehensive Cancer Center University of California, Irvine; Phone Number: 1-877-827-7883; Email: ucstudy@uci.edu
• Study Contact Backup: Name: University of California Irvine Medical

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Chao Family Comprehensive Cancer Center, University of California, Irvine
      • Contact: Maheswari Senthil, MD FACS; Phone Number: 877-827-8839; Email: ucstudy@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients must have peritoneal carcinomatosis from a GI primary tumor
• Must have planned standard of care surgical procedure
• Age ≥ 18 years.
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Pattens who are unable to comply with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subjects with Gastrointestinal Peritoneal Carcinomatosis; Subjects with gastrointestinal (GI) peritoneal carcinomatosis who are undergoing planned standard of care (SOC) surgical procedures. Biospecimens such as blood, peritoneal wash fluid and tumor samples will be obtained.	Other: Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples); Subjects with a known diagnosis of GI PC, with a planned standard of care surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of angioarchitechture of peritoneal lesions through Optical Coherence Tomography Angiography (OCTA)	Establishment and evaluation of angioarchitecture of peritoneal lesions through OCTA imaging obtained during surgery.	Up to 4 years
Development of individual patient-derived peritoneal carcinomatosis (pdPC) vascularized micro-tumor (VMT)	Successful establishment of multicellular pdPC VMT models from metastatic and/or primary tumor tissue with increasing tumor volume over a 14 day period.	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare response of therapeutic regimens in a pdPC VMT to the observed clinical response (by RECIST criteria or diagnostic laparoscopy)	Response to therapy in a pdPC VMT will be correlated with the clinical response observed in patients treated with similar regimens using either RECIST criteria if measurable disease is available or by diagnostic laparoscopy performed as part of standard of care to assess treatment response	Up to 4 years
Overall Survival (OS)	Survival analysis will utilized to study association between in vitro model and patient clinical response. The duration of time from start of treatment to time of progression or death, whichever occurs first.	Up to 4 years
Progression-Free Survival (PFS) at 6 months	Survival analysis will utilized to study association between in vitro model and patient clinical response. Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 months will be made.	6 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Maheswari Senthil, MD FACS, Chao Family Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Peritoneal Carcinomatosis; Gastrointestinal Peritoneal Carcinomatosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Digestive System Neoplasms; Abdominal Neoplasms; Carcinoma; Peritoneal Neoplasms
• Other Study ID Numbers: UCI 22-92 [HS# 2214]; 2214 (Other Identifier: University of California, Irvine)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No