Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy

Northwell Health

Status: Active, not recruiting

Conditions: Metastatic Pancreatic Cancer

Treatments: Diagnostic Test: Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA)

Study type: Observational

Funder types: Other

Identifiers

NCT07122466

23-0286

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.