Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)
Other interventionSubjects with a known diagnosis of GI primary tumor with or without PC, with a planned standard of care surgery.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Subjects with Gastrointestinal Primary Tumor with or without Peritoneal CarcinomatosisOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 4 years2
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.
Time frame
Up to 4 yearsSecondary outcomes
1
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
Time frame
Up to 4 years2
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.
Time frame
6 months3
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.
Time frame
Up to 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov