Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy

Active, not recruiting

• Conditions: Metastatic Pancreatic Cancer

• Registration Number: NCT07122466
• Lead Sponsor: Northwell Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-22
• Primary Completion: 2023-10-17
• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First follow-up imaging assessment	2 months	Compare first follow-up imaging assessment at 2 months with tumor response as assessed by ctDNA level change from baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zuckerberg Cancer Center; 🇺🇸 New Hyde Park, New York, United States