Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
2 other identifiers
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2023
CompletedStudy Start
First participant enrolled
May 4, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 29, 2025
July 1, 2025
3.6 years
January 27, 2023
July 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Compare response of therapeutic regimens in a pdPC VMT to the observed clinical response (by RECIST criteria or diagnostic laparoscopy)
Up to 4 years
Progression-Free Survival (PFS) at 6 months
6 months
Overall Survival (OS)
Up to 4 years
Study Arms (1)
Subjects with Gastrointestinal Primary Tumor with or without Peritoneal Carcinomatosis
OTHERSubjects with gastrointestinal (GI) primary tumor with or without 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.
Interventions
Subjects with a known diagnosis of GI primary tumor with or without PC, with a planned standard of care surgery.
Eligibility Criteria
You may qualify if:
- Patients must have a GI tumor
- Must have planned standard of care surgical procedure
- Age ≥ 18 years.
- Ability to understand and the willingness to sign a written informed consent
You may not qualify if:
- \- Pattens who are unable to comply with the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maheswari Senthil, MD FACS
Chao Family Comprehensive Cancer Center
Central Study Contacts
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
University of California Irvine Medical
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery, Division Chief - Surgical Oncology
Study Record Dates
First Submitted
January 27, 2023
First Posted
May 6, 2023
Study Start
May 4, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 29, 2025
Record last verified: 2025-07