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Diagnostic Test

ctDNA Blood Collection for Pancreatic and Liver Cancer

N/A

Recruiting

Led By Nadine Abi-Jaoudeh, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have or are undergoing work-up for hepatobiliary and/or pancreatic carcinoma (such as hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, pancreatic carcinoma)

18 years of age or older

Must not have

Patients with moderate to severe ascites who cannot undergo trans-jugular biopsy or sufficient drainage

Patients with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether taking samples from the cancer draining vein will produce more accurate results than taking samples from a peripheral vein for patients with hepatobiliary and pancreatic cancers.

Who is the study for?

This trial is for adults over 18 with suspected or confirmed hepatobiliary or pancreatic cancers, such as liver, bile duct, ampullary, or pancreatic cancer. They must be scheduled for a biopsy and able to consent. Excluded are those who can't stay still during procedures, weigh over 375 pounds, have severe clotting issues or ascites preventing biopsy.

What is being tested?

The study is testing if collecting ctDNA (circulating tumor DNA) from the vein draining the cancer site gives better results than from a standard peripheral blood draw in patients undergoing biopsies for certain abdominal cancers.

What are the potential side effects?

Since this trial involves blood collection and not drug intervention, side effects may include discomfort at the needle insertion site, bruising, bleeding risk especially in those with clotting disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am being evaluated for liver, bile duct, or pancreatic cancer.

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I am 18 years old or older.

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I am scheduled for a biopsy guided by imaging.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe fluid buildup in my abdomen that cannot be drained or biopsied through the neck.

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I weigh less than or equal to 375 pounds.

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I have a blood clotting disorder that cannot be corrected.

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I can stay still and hold my breath for procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency

Secondary study objectives

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

Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ctDNA collection from draining and peripheral veinsExperimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met