Metastatic Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer
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.
Interventions
DIAGNOSTIC_TESTTumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA)
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.
Sponsors
Northwell Health
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel King, MD
Northwell Health
Outcome results
None listed