Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

Sponsor

University of California, Irvine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05844865

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Carcinomatosis Gastrointestinal Peritoneal Carcinomatosis	Other: Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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 [Up to 4 years]
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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chao Family Comprehensive Cancer Center, University of California, Irvine	Orange	California	United States	92868

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator: Maheswari Senthil, MD FACS, Chao Family Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maheswari Senthil, MD, Professor of Surgery, Division Chief - Surgical Oncology, University of California, Irvine

ClinicalTrials.gov Identifier:

NCT05844865

Other Study ID Numbers:

UCI 22-92 [HS# 2214]
2214

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maheswari Senthil, MD, Professor of Surgery, Division Chief - Surgical Oncology, University of California, Irvine

Peritoneal Carcinomatosis

Gastrointestinal Peritoneal Carcinomatosis

Additional relevant MeSH terms:

Carcinoma

Peritoneal Neoplasms

Study Results

No Results Posted as of May 6, 2023