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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am being evaluated for liver, bile duct, or pancreatic cancer.
Select...
I am 18 years old or older.
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I am scheduled for a biopsy guided by imaging.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency
Secondary outcome measures
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
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.
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,986 Total Patients Enrolled
1 Trials studying Liver Cancer
Nadine Abi-Jaoudeh, MDPrincipal InvestigatorChao Family Comprehensive Cancer Center
4 Previous Clinical Trials
213 Total Patients Enrolled
1 Trials studying Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am being evaluated for liver, bile duct, or pancreatic cancer.I am 18 years old or older.I weigh less than or equal to 375 pounds.You are unable to have a blood test to check for ctDNA.I have severe fluid buildup in my abdomen that cannot be drained or biopsied through the neck.Your platelet count is less than 30,000 per microliter.Your blood takes longer than usual to clot.I have a blood clotting disorder that cannot be corrected.I am scheduled for a biopsy guided by imaging.I can stay still and hold my breath for procedures.My condition does not have a clear target for biopsy through skin or vein.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the current recruitment period still open for enrollment in this study?
"According to the data posted on clinicaltrials.gov, this research endeavour is still actively recruiting participants with an original posting date of September 7th 2022 and a latest update on September 19th 2022."
Answered by AI
How many individuals have been enrolled in this trial thus far?
"Affirmative. Clinicaltrials.gov confirms that this research is actively enrolling participants, with the initial post date being September 7th 2022 and most recent update occurring on September 19th 2022. The clinical trial requires 15 new test subjects from a single medical facility."
Answered by AI
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