Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy

NCT07122466 | Active Not Recruiting

• 1 other identifier: 23-0286
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ctDNA Assessment Comparison

  2 months

• Compare Signatera ctDNA test

  6 months

• ctDNA, CA19-9, & CEA Response

  6 months

Other Outcomes (2)

• Exploratory - Organoid Samples

  2 months

• Exploratory - Sample Size

  6 months

Interventions

Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Prior/Concurrent Therapy Criteria
• Patients must be initiating a new treatment regimen for pancreatic cancer at the time of their initiation in the study
• Patients must have cytologic or histologic confirmation of pancreatic cancer
• Patients must have measurable radiographic evidence of metastatic disease
• Patients must be ≥18 years of age
• Patients must have an ECOG Performance Status 0-2.
• Patients must have adequate organ function for delivery of chemotherapy as evidenced by the following: Hgb ≥8 g/dL, platelets ≥ 75
• Patients must not have renal dysfunction that would prevent administration of IV contrast for radiographic assessment.
• Regulatory Criteria
• 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.
• Patients of all races, genders, \& ethnicities are eligible.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Zuckerberg Cancer Center

New Hyde Park, New York, 11042, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Daniel King, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: May 22, 2023
• Primary Completion: October 17, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

US (1)