Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

University of California, Irvine20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Peritoneal Carcinomatosis Gastrointestinal Peritoneal Carcinomatosis

Interventions

Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)OTHER

Subjects with a known diagnosis of GI primary tumor with or without PC, with a planned standard of care surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 4 years

Secondary Outcomes

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

Time frame: 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.

Time frame: 6 months

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.

Time frame: Up to 4 years

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-7883 ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Data from ClinicalTrials.gov

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