Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

Peritoneal Carcinomatosis Clinical Trial

Official title:

Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844865
• Other study ID #: UCI 22-92 [HS# 2214]
• Secondary ID: 2214
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: University of California, Irvine
• Contact: Chao Family Comprehensive Cancer Center University of California
• Phone: 1-877-827-7883
• Email: ucstudy[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Chao Family Comprehensive Cancer Center, University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Up to 4 years
Secondary	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.	6 months
Secondary	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.	Up to 4 years