Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

Study Overview
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Brief Summary
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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.

Official Title
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Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

Conditions
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Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis

Intervention / Treatment
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* Other: Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have peritoneal carcinomatosis from a GI primary 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects with Gastrointestinal Peritoneal Carcinomatosis<br>Subjects with gastrointestinal (GI) 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. | Other: Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)<br>* Subjects with a known diagnosis of GI PC, with a planned standard of care surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal Carcinomatosis, Gastrointestinal Peritoneal Carcinomatosis