Recruiting NCT05844865
Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples).
- Who it may be relevant to
- Registry conditions: Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Other Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)
Subjects with a known diagnosis of GI primary tumor with or without PC, with a planned standard of care surgery.
Primary outcome measures
- Establishment of angioarchitechture of peritoneal lesions through Optical Coherence Tomography Angiography (OCTA) [Time frame: Up to 4 years]
- Development of individual patient-derived peritoneal carcinomatosis (pdPC) vascularized micro-tumor (VMT) [Time frame: Up to 4 years]
Secondary outcome measures (3)
- Compare response of therapeutic regimens in a pdPC VMT to the observed clinical response (by RECIST criteria or diagnostic laparoscopy) [Time frame: Up to 4 years]
- Progression-Free Survival (PFS) at 6 months [Time frame: 6 months]
- Overall Survival (OS) [Time frame: Up to 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange
Identifiers
NCT: NCT05844865 · 2214 · UCI 22-92