Early Treatment CtDNA Dynamics To Predict Response To Chemotherapy

Study Overview

Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy

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.

N/A

Metastatic Pancreatic Cancer

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

23-0286

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-08-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-07
First Submitted that Met QC Criteria 2025-08-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-14
First Posted (ACTUAL) 2025-08-14	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Daniel King, MD, Northwell Health

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record