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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • ctDNA Blood Collection

    Diagnostic test

    Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: ctDNA collection from draining and peripheral veinsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 1 year

Secondary outcomes

1

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)

Time frame
Up to 1 year
2

Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS)

ctDNA results will be compared with percutaneous biopsy (standard of care)

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.