RECRUITING

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

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Conditions

Hepatobiliary CancerPancreatic CancerHepatocellular CarcinomaCholangiocarcinomaAmpullary CancerPancreatic CarcinomactDNACirculating Tumor DNA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-09-07
Study Completion:2024-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05497531

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Have or are undergoing work-up for hepatobiliary and/or pancreatic carcinoma (such as hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, pancreatic carcinoma)
  3. * Scheduled for an image-guided percutaneous or trans-jugular biopsy of a lesion
  4. * Must be able to provide a written informed consent
  1. * Patients unable to hold reasonably still on a procedure table or hold their breath during imaging or needle passes
  2. * Patients with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
  3. * Patients with uncorrectable coagulopathy
  4. * Platelet count \< 30,000/ul
  5. * International Normalized (INR) \> 1.5
  6. * Patients with moderate to severe ascites who cannot undergo trans-jugular biopsy or sufficient drainage
  7. * No clear reachable target for percutaneous or trans-jugular biopsy
  8. * Patient who cannot have a peripheral blood draw for ctDNA

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
1-877-827-7883
ucstudy@uci.edu
University of California Irvine Medical
CONTACT

Principal Investigator

Nadine Abi-Jaoudeh, MD
PRINCIPAL_INVESTIGATOR
Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Nadine Abi-Jaoudeh, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-07
Study Completion Date2024-10

Study Record Updates

Study Start Date2022-09-07
Study Completion Date2024-10

Terms related to this study

Keywords Provided by Researchers

  • ctDNA
  • Circulating Tumor DNA
  • Pancreatic Cancer
  • Hepatobiliary Cancer

Additional Relevant MeSH Terms

  • Hepatobiliary Cancer
  • Pancreatic Cancer
  • Hepatocellular Carcinoma
  • Cholangiocarcinoma
  • Ampullary Cancer
  • Pancreatic Carcinoma