Peritoneal CarcinomatosisNCT05844865
Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
A study testing Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples) in people with Peritoneal Carcinomatosis and Gastrointestinal Peritoneal Carcinomatosis, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis
- What is being tested?
- Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pattens who are unable to comply with the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Maheswari Senthil, MD FACS, 877-827-8839, ucstudy@uci.edu
About this study
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.
- Being tested
- Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)
- Keywords
- Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)Other
Subjects with a known diagnosis of GI primary tumor with or without PC, with a planned standard of care surgery.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Gastrointestinal Primary Tumor with or without Peritoneal Carcinomatosis | Other | Subjects with gastrointestinal (GI) primary tumor with or without 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. Receives: Other: Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years
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.
Measured: Up to 4 years
Secondary outcomes (3)
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
Measured: Up to 4 years
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.
Measured: 6 months
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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start4 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maheswari Senthil, MD, University of California, Irvine
- Investigators
- Maheswari Senthil, MD FACS, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844865
- Sponsor's protocol ID
- 2214
- Other IDs
- UCI 22-92
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No