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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497531
• Other study ID #: 1491
• Secondary ID: UCI 21-124
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: University of California, Irvine
• Contact: Chao Family Comprehensive Cancer Center University of California
• Phone: 1-877-827-7883
• Email: ucstudy[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• ctDNA Blood Collection
Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy

Locations

Country	Name	City	State
United States	Chao Family Comprehensive Cancer Center, University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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)	Up to 1 year