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| ID | Type | Description | Link |
|---|---|---|---|
| UCI 22-92 | Other Identifier | CFCCC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Pattens who are unable to comply with the study protocol
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Contact | 1-877-827-7883 | ucstudy@uci.edu | |
| University of California Irvine Medical | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Maheswari Senthil, MD FACS | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California, Irvine | Recruiting | Orange | California | 92868 | United States |
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| 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 |
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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