Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy

Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy in Patients With Advanced Pancreatic Cancer: a Prospective, Observational Pilot Study

This is a study that aims to understand whether a blood test measuring tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) shows a similar response as observed by a follow-up CT scan. To study this question, ctDNA will be measured at the same times as CT scans (just before the start of treatment, as well as 2 months after), and the response measured by the ctDNA change will be compared to the response seen on the changes between the CT scans. The goal is to make sure that ctDNA response correlates well with CT scan response measurement.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Diagnostic test: Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA)

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11042
      • Zuckerberg Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The proposed sample size of 20 subjects is based on feasibility and availability of resources and not on a formal power calculation. The number of subjects is small, so as to quickly gather data that could inform a larger study.

Description

Inclusion Criteria:

Prior/Concurrent Therapy Criteria

1. Patients must be initiating a new treatment regimen for pancreatic cancer at the time of their initiation in the study
2. Patients must have cytologic or histologic confirmation of pancreatic cancer
3. Patients must have measurable radiographic evidence of metastatic disease
4. Patients must be ≥18 years of age
5. Patients must have an ECOG Performance Status 0-2.
6. Patients must have adequate organ function for delivery of chemotherapy as evidenced by the following: Hgb ≥8 g/dL, platelets ≥ 75

7. Patients must not have renal dysfunction that would prevent administration of IV contrast for radiographic assessment.

   Regulatory Criteria

8. Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.
9. Patients of all races, genders, & ethnicities are eligible.

Exclusion Criteria:

No exclusion criteria.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First follow-up imaging assessment	Compare first follow-up imaging assessment at 2 months with tumor response as assessed by ctDNA level change from baseline	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA Assessment Comparison	Compare ctDNA assessment at 2 months with earlier ctDNA measurements	2 months
Compare Signatera ctDNA test	Compare Signatera ctDNA test with another vendor	6 months
ctDNA, CA19-9, & CEA Response	Compare response of ctDNA with response of CA19-9 and CEA	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory - Organoid Samples	If organoid samples are available, compare drug response assessment from organoids to clinical response assessment at 2 months.	2 months
Exploratory - Sample Size	If sample size has enough power, to compare differences in early ctDNA response between regimens (FOLFIRINOX vs Gemcitabine-based treatment, at 3 days and 1 week, respectively)	6 months

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Daniel King, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Actual): October 17, 2023
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 7, 2025
• First Submitted That Met QC Criteria: August 7, 2025
• First Posted (Actual): August 14, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pancreatic Cancer
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 23-0286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No