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Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

Primary Purpose

Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Peritoneal Carcinomatosis focused on measuring Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chao Family Comprehensive Cancer Center, University of California, IrvineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Subjects with Gastrointestinal Peritoneal Carcinomatosis

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
January 27, 2023
Last Updated
May 15, 2023
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT05844865
Brief Title
Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
Official Title
Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis
Keywords
Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects with Gastrointestinal Peritoneal Carcinomatosis
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)
Intervention Description
Subjects with a known diagnosis of GI PC, with a planned standard of care surgery.
Primary Outcome Measure Information:
Title
Establishment of angioarchitechture of peritoneal lesions through Optical Coherence Tomography Angiography (OCTA)
Description
Establishment and evaluation of angioarchitecture of peritoneal lesions through OCTA imaging obtained during surgery.
Time Frame
Up to 4 years
Title
Development of individual patient-derived peritoneal carcinomatosis (pdPC) vascularized micro-tumor (VMT)
Description
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 Outcome Measure Information:
Title
Compare response of therapeutic regimens in a pdPC VMT to the observed clinical response (by RECIST criteria or diagnostic laparoscopy)
Description
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
Title
Progression-Free Survival (PFS) at 6 months
Description
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
Title
Overall Survival (OS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Family Comprehensive Cancer Center University of California, Irvine
Phone
1-877-827-7883
Email
ucstudy@uci.edu
First Name & Middle Initial & Last Name or Official Title & Degree
University of California Irvine Medical
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maheswari Senthil, MD FACS
Organizational Affiliation
Chao Family Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center, University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maheswari Senthil, MD FACS
Phone
877-827-8839
Email
ucstudy@uci.edu

12. IPD Sharing Statement

Learn more about this trial

Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

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