Gastrointestinal Peritoneal Carcinomatosis, Peritoneal Carcinomatosis
Conditions
Keywords
Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis
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.
Interventions
OTHERBiospecimen 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.
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | 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. |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORMaheswari Senthil, MD FACS
Chao Family Comprehensive Cancer Center
Outcome results
None listed