Clinical trial · Observational
Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy
Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy in Patients With Advanced Pancreatic Cancer: a Prospective, Observational Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- First follow-up imaging assessment
- timeFrame
- 2 months
- description
- Compare first follow-up imaging assessment at 2 months with tumor response as assessed by ctDNA level change from baseline
Secondary outcomes (3)
- measure
- ctDNA Assessment Comparison
- timeFrame
- 2 months
- description
- Compare ctDNA assessment at 2 months with earlier ctDNA measurements
- measure
- Compare Signatera ctDNA test
- timeFrame
- 6 months
- description
- Compare Signatera ctDNA test with another vendor
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available