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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT05844865
- Acronym / sponsor ID
- 2214
- Keywords
- Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Gastrointestinal Primary Tumor with or without Peritoneal Carcinomatosis | Other | Other: Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pattens who are unable to comply with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Subjects with Gastrointestinal Primary Tumor with or without Peritoneal Carcinomatosis |
Primary outcome
Establishment of angioarchitechture of peritoneal lesions through Optical Coherence Tomography Angiography (OCTA)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Maheswari Senthil, MD FACS principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-7883, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of angioarchitechture of peritoneal lesions through Optical Coherence Tomography Angiography (OCTA) (time frame: Up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.