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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment ctDNA Blood Collection for pancreatic and liver cancer?

Research shows that circulating tumor DNA (ctDNA) can help detect minimal residual disease and predict treatment response in pancreatic cancer, making it a promising tool for monitoring and managing the disease. It can also provide early diagnostic information, which is crucial for improving outcomes in pancreatic cancer patients. ^{1 2 3 4 5}

Is ctDNA blood collection safe for humans?

The research on ctDNA blood collection primarily focuses on its use as a biomarker for monitoring cancer, and there is no specific mention of safety concerns in the studies. However, since it involves a blood draw, it is generally considered safe, similar to other routine blood tests. ^{6 7 8 9 10}

How is ctDNA Blood Collection treatment different from other treatments for pancreatic and liver cancer?

ctDNA Blood Collection is unique because it involves a 'liquid biopsy', which is a simple blood test that detects circulating tumor DNA (ctDNA) to provide diagnostic information. This approach is less invasive than traditional biopsies and can help in early detection and monitoring of pancreatic and liver cancer, potentially leading to more personalized treatment options. ^{3 4 11 12 13}

Research Team

Nadine Abi-Jaoudeh, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Eligibility Criteria

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.

I am 18 years old or older.

Must be able to provide a written informed consent

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Emerging Role of Circulating Tumor DNA in Non-Colorectal Gastrointestinal Cancers. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Circulating tumor DNA (ctDNA) to evaluate minimal residual disease (MRD), treatment response, and posttreatment prognosis in pancreatic adenocarcinoma. [2023]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Circulating tumor DNA as a liquid biopsy target for detection of pancreatic cancer. [2018]

5. Japan pubmed.ncbi.nlm.nih.gov

Circulating tumor DNA as a predictive marker for occult metastases in pancreatic cancer patients with radiographically non-metastatic disease. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Analysis of ctDNA to predict prognosis and monitor treatment responses in metastatic pancreatic cancer patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical relevance of circulating KRAS mutated DNA in plasma from patients with advanced pancreatic cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Circulating Tumor DNA as a Clinical Test in Resected Pancreatic Cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Peripheral and Portal Venous KRAS ctDNA Detection as Independent Prognostic Markers of Early Tumor Recurrence in Pancreatic Ductal Adenocarcinoma. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Molecular profiling of ctDNA in pancreatic cancer: Opportunities and challenges for clinical application. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Detection of Circulating Tumor DNA in Patients with Pancreatic Cancer Using Digital Next-Generation Sequencing. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Bile-Based Cell-Free DNA Analysis Is a Reliable Diagnostic Tool in Pancreatobiliary Cancer. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Circulating tumour DNA: a challenging innovation to develop "precision onco-surgery" in pancreatic adenocarcinoma. [2023]