ctDNA Blood Collection for Pancreatic and Liver Cancer

Overseen By Chao Family Comprehensive Cancer Center University of California, Irvine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Coagulopathy, Low platelets, High INR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if collecting blood from a vein closer to the cancer detects cancer DNA more effectively than using a vein in the arm. It focuses on individuals with suspected pancreatic or liver cancers who are already scheduled for a biopsy. Participants must be undergoing a biopsy for their condition and able to remain still during the procedure. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cancer detection methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for patients undergoing biopsies?

Research has shown that collecting circulating tumor DNA (ctDNA) from blood primarily monitors cancer. Studies have found no safety concerns with this method. Collecting ctDNA offers a non-invasive way to obtain genetic information about tumors, avoiding surgery or other invasive procedures. This approach is generally easy for patients to tolerate. The main focus remains on how effectively it provides useful information, rather than any risk to patients. So far, studies have not reported any specific side effects from collecting ctDNA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ctDNA blood collection for pancreatic and liver cancer because it offers a new way to detect cancer using a blood sample. Unlike traditional methods that rely on tissue biopsies, which can be invasive and uncomfortable, this approach uses a simple blood draw to collect circulating tumor DNA (ctDNA). By analyzing ctDNA from the cancer-draining veins, doctors might get more precise information about the cancer, potentially leading to earlier detection and better treatment decisions. This method could revolutionize how we monitor and diagnose these cancers, making the process safer and more convenient for patients.

What evidence suggests that this protocol is effective for detecting ctDNA in pancreatic and liver cancer?

Research has shown that tiny pieces of DNA from cancer cells, known as circulating tumor DNA (ctDNA), can be found in the blood and help detect pancreatic and liver cancers. This trial involves collecting ctDNA from draining and peripheral veins in patients undergoing diagnostic work-up for suspected primary hepatobiliary or pancreatic cancer. One study found that if ctDNA with certain changes, such as KRAS mutations, appears after surgery for pancreatic cancer, it may indicate a worse outcome. Another study demonstrated that ctDNA testing can improve cancer detection when it considers specific tumor traits. Additionally, ctDNA tests align well with traditional tissue tests in identifying important cancer mutations for treatment. This suggests that ctDNA blood tests might offer a non-invasive way to detect these cancers and predict patient outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Nadine Abi-Jaoudeh, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Must be able to provide a written informed consent

I am scheduled for a biopsy guided by imaging.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy and Blood Sampling

Participants undergo a biopsy procedure and blood sampling from both the cancer draining vein and a peripheral vein

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy and blood sampling

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• ctDNA Blood Collection

Trial Overview

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.

How Is the Trial Designed?

Group I: ctDNA collection from draining and peripheral veins Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

Detectable circulating tumor DNA (ctDNA), particularly mutated KRAS, after surgical resection in pancreatic adenocarcinoma is associated with poorer outcomes, including shorter recurrence-free survival and overall survival, indicating its potential as a prognostic marker.

There is emerging evidence that ctDNA may serve as a noninvasive tool to evaluate treatment response to chemotherapy, although more research is needed to determine how this information can influence treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating tumor DNA (ctDNA) to evaluate minimal residual disease (MRD), treatment response, and posttreatment prognosis in pancreatic adenocarcinoma. Ueberroth, BE., Jones, JC., Bekaii-Saab, TS.[2023]

Circulating tumor DNA (ctDNA) detection is a valuable tool in managing gastrointestinal cancers, as it can indicate prognosis and the presence of minimal residual disease (MRD) after surgery, which is linked to a higher risk of cancer recurrence.

CtDNA assays allow for comprehensive genomic profiling, enabling the identification of cancer mutations without needing tumor tissue, and can track changes in cancer characteristics over time, which is particularly useful in monitoring treatment responses and resistance mechanisms in specific cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Circulating Tumor DNA in Non-Colorectal Gastrointestinal Cancers. Lee, MS., Kaseb, AO., Pant, S.[2023]

In a study involving 59 patients with pancreatic ductal adenocarcinoma (PDAC), circulating tumor DNA (ctDNA) was found in 49% of preoperative samples and was a strong predictor of decreased recurrence-free survival and overall survival.

Patients who underwent neoadjuvant chemotherapy had significantly lower rates of preoperative ctDNA detection (21%) compared to those who did not receive chemotherapy (69%), indicating that ctDNA levels can reflect treatment response and may help in monitoring disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating Tumor DNA as a Clinical Test in Resected Pancreatic Cancer. Groot, VP., Mosier, S., Javed, AA., et al.[2022]

In a study of 14 patients with advanced pancreatic cancer, the presence of circulating tumor DNA (ctDNA) with KRAS mutations before chemotherapy was linked to a higher likelihood of disease progression, with 90% of ctDNA-positive patients experiencing progression compared to only 25% of ctDNA-negative patients.

The levels of ctDNA before treatment were significant predictors of both progression-free and overall survival, suggesting that ctDNA could be a valuable marker for monitoring treatment efficacy and disease progression in pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical relevance of circulating KRAS mutated DNA in plasma from patients with advanced pancreatic cancer. Tjensvoll, K., Lapin, M., Buhl, T., et al.[2022]

Circulating tumor DNA (ctDNA) from liquid biopsies offers a promising method for characterizing pancreatic ductal adenocarcinoma (PDAC) genomes, potentially leading to better diagnosis and treatment options, especially given the challenges of traditional tissue biopsies.

ctDNA analysis can help identify new therapeutic targets and biomarkers for treatment response, which is crucial for advancing precision medicine in managing PDAC, a cancer with limited effective treatments and poor prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular profiling of ctDNA in pancreatic cancer: Opportunities and challenges for clinical application. Sivapalan, L., Kocher, HM., Ross-Adams, H., et al.[2021]

In a study of 165 pancreatic cancer patients, circulating tumor DNA (ctDNA) was found to be significantly more prevalent in those with occult metastases (41.0%) compared to those without (14.6%), indicating its potential as a predictive biomarker.

ctDNA was identified as an independent predictor of occult metastases, with a hazard ratio of 6.311, suggesting that its presence can help assess prognosis in treatment-naïve patients without apparent metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating tumor DNA as a predictive marker for occult metastases in pancreatic cancer patients with radiographically non-metastatic disease. Hata, T., Mizuma, M., Iseki, M., et al.[2021]

Digital next-generation sequencing (NGS) effectively detects circulating tumor DNA (ctDNA) in patients with pancreatic cancer, identifying positive KRAS mutations in 37% of patients, including 31% in early-stage disease.

However, the method faces challenges with false-positive results, as low-level mutations were also detected in healthy and disease controls, likely due to DNA modifications and sequencing errors rather than true mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Circulating Tumor DNA in Patients with Pancreatic Cancer Using Digital Next-Generation Sequencing. Macgregor-Das, A., Yu, J., Tamura, K., et al.[2021]

Circulating tumor DNA (ctDNA) is a promising biomarker for pancreatic ductal adenocarcinoma (PDAC), providing real-time insights into tumor characteristics and potential therapeutic targets, which could enhance treatment strategies.

While ctDNA shows excellent specificity and is useful for assessing minimal residual disease post-surgery, its current sensitivity is limited, particularly in patients with low tumor burden, highlighting the need for further development to improve its clinical utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating tumour DNA: a challenging innovation to develop "precision onco-surgery" in pancreatic adenocarcinoma. Pietrasz, D., Sereni, E., Lancelotti, F., et al.[2023]

The study identified specific mutations in circulating tumor DNA (ctDNA) from 188 patients with metastatic pancreatic cancer, with the ERBB2 exon17 mutation linked to poorer overall survival, highlighting its potential as a prognostic biomarker.

ctDNA detection showed a high correlation (76.9%) with treatment response as seen in CT imaging, suggesting that monitoring ctDNA could provide early insights into how well a patient is responding to chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of ctDNA to predict prognosis and monitor treatment responses in metastatic pancreatic cancer patients. Cheng, H., Liu, C., Jiang, J., et al.[2022]

Pancreatic cancer often goes undetected until it is advanced, leading to very low survival rates, highlighting the urgent need for early detection methods.

Liquid biopsies, which analyze circulating tumor DNA (ctDNA) from blood samples, show promise as a minimally invasive diagnostic tool that could enable earlier detection and potentially improve treatment options for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating tumor DNA as a liquid biopsy target for detection of pancreatic cancer. Takai, E., Yachida, S.[2018]

In a study of 221 blood samples from 108 pancreatic ductal adenocarcinoma (PDAC) patients, KRAS ctDNA was found to be a significant prognostic marker, with higher detection rates in palliative patients compared to those receiving curative treatment (58.1% vs 24.6%).

KRAS mutations detected in portal venous blood were associated with shorter recurrence-free survival and overall survival, indicating that this method could enhance clinical decision-making for treatment strategies in PDAC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral and Portal Venous KRAS ctDNA Detection as Independent Prognostic Markers of Early Tumor Recurrence in Pancreatic Ductal Adenocarcinoma. Nitschke, C., Markmann, B., Walter, P., et al.[2023]

In a study of 55 patients with borderline-resectable pancreatic cancer, positive circulating tumor DNA (ctDNA) status after surgery was linked to significantly shorter overall survival, indicating its potential as a biomarker for poor prognosis.

Combining postoperative ctDNA results with CA19-9 levels enhanced the predictive power for relapse-free survival and overall survival, suggesting that monitoring these biomarkers could help identify patients at higher risk for poor outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating Tumor DNA as a Potential Prognostic Marker in Patients with Borderline-Resectable Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy Followed by Pancreatectomy. Kitahata, Y., Kawai, M., Hirono, S., et al.[2022]

Bile is a promising source of cell-free DNA (cfDNA) for detecting genetic mutations in pancreatobiliary cancers, successfully identifying 96.2% of mutations found in matched tissue samples, compared to only 31.6% from plasma.

Using bile for cfDNA analysis could provide a less invasive alternative for diagnosing pancreatobiliary cancers and monitoring disease, especially when traditional tissue biopsies are not possible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bile-Based Cell-Free DNA Analysis Is a Reliable Diagnostic Tool in Pancreatobiliary Cancer. Driescher, C., Fuchs, K., Haeberle, L., et al.[2021]

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The objective of this study is to assess the role of serial ctDNA analysis as integrative biomarker in patients with resectable or borderline resectable ...

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In this review, we highlight recent developments in the use of ctDNA-based liquid biopsies for PDAC and provide new insights into the technical, analytical and ...