Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

Not Applicable

Recruiting

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

• Registration Number: NCT05844865
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-05-02
• Study Start: 2023-05-04
• Study First Posted: 2023-05-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• Pattens who are unable to comply with the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with Gastrointestinal Primary Tumor with or without Peritoneal Carcinomatosis	Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)	Subjects 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 4 years	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.
Compare response of therapeutic regimens in a pdPC VMT to the observed clinical response (by RECIST criteria or diagnostic laparoscopy)	Up to 4 years	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
Progression-Free Survival (PFS) at 6 months	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.

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine; 🇺🇸 Orange, California, United States