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NCT05497531 | RECRUITING | Hepatobiliary Cancer

Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
Sponsor:

University of California, Irvine

Information provided by (Responsible Party):

Nadine Bakdah

Brief Summary:

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.

Condition or disease

Hepatobiliary Cancer

Pancreatic Cancer

Hepatocellular Carcinoma

Cholangiocarcinoma

Ampullary Cancer

Pancreatic Carcinoma

Intervention/treatment

ctDNA Blood Collection

Phase

NA

Detailed Description:

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Pilot Trial Comparing Circulating Tumor DNA (ctDNA) From Immediate Draining Vein vs. Standard Peripheral Vein Sample in Patients Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
Actual Study Start Date : 2022-09-07
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 18 years of age or older
  • * Have or are undergoing work-up for hepatobiliary and/or pancreatic carcinoma (such as hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, pancreatic carcinoma)
  • * Scheduled for an image-guided percutaneous or trans-jugular biopsy of a lesion
  • * Must be able to provide a written informed consent
Exclusion Criteria
  • * Patients unable to hold reasonably still on a procedure table or hold their breath during imaging or needle passes
  • * Patients with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
  • * Patients with uncorrectable coagulopathy
  • * Platelet count \< 30,000/ul
  • * International Normalized (INR) \> 1.5
  • * Patients with moderate to severe ascites who cannot undergo trans-jugular biopsy or sufficient drainage
  • * No clear reachable target for percutaneous or trans-jugular biopsy
  • * Patient who cannot have a peripheral blood draw for ctDNA
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers

Location Details

NCT05497531

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How to Participate

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Locations

RECRUITING

United States, California

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States, 92868