Peritoneal Carcinomatosis Clinical Trial
Official title:
Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Chao Family Comprehensive Cancer Center, University of California, Irvine | Orange | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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