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| ID | Type | Description | Link |
|---|---|---|---|
| UCI 21-124 | Other Identifier | UCI CFCCC |
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This is a prospective pilot protocol investigating whether ctDNA detection be improved by sampling the cancer draining vein versus the standard practice of sampling from a peripheral vein in patients who are undergoing biopsies for hepatobiliary and pancreatic cancers.
This is a, prospective single center pilot study to investigate whether ctDNA detection can be improved by sampling the cancer draining vein vs. a peripheral vein (current practice). As a secondary endpoint, both ctDNA results will be compared with percutaneous biopsy (standard of care).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ctDNA collection from draining and peripheral veins | Experimental | Patient with suspected primary hepatobiliary or pancreatic cancer undergoing a diagnostic work-up with a percutaneous or trans-jugular biopsy (standard of care) and will undergo a sampling of the cancer draining vein during their biopsy procedure with a collection of an additional 10mL of blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ctDNA Blood Collection | Diagnostic Test | Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency | Ratio of mean allele frequency (MAF)% of hepatic or portal draining vein, and MAF% of peripheral blood will be utilized to compare the samples | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma | ctDNA results will be compared with percutaneous biopsy (standard of care) | Up to 1 year |
| Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS) |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|
| Nadine Abi-Jaoudeh, MD | 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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ctDNA results will be compared with percutaneous biopsy (standard of care) |
| Up to 1 year |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
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