Clinical trial · Observational
Evaluating the Prognostic Capability of ctDNA as a Biomarker in Pancreatic Cancer Patients Undergoing Neoadjuvant Chemotherapy
NCT04616131CI-TRIAL-00115211recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
For patients who have been diagnosed with pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes. The purpose of this research study is to understand if we are able to detect pancreatic cancer DNA in the blood stream before, during, and after treatment.
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 |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients with circulating tumor DNA (ctDNA) levels as not detectable in their blood compared to number of patients with ctDNA detected.
- timeFrame
- 3 months
- description
- Utilizing Tempus, a commercial laboratory ctDNA genetic profile panel investigators will analyze the number of patients who had detectable ctDNA in their blood prior to neoadjuvant chemotherapy who then had no detectable ctDNA after their chemotherapy treatment.
Secondary outcomes (1)
- measure
- Investigators will look for statistically significant correlations of ctDNA blood levels with clinical treatment responses of tumor grades, CA 19-9 units/milliliter blood level, and radiologic response by RECIST categories of complete response.
- timeFrame
- 12 months
- description
- Association of ctDNA clearance with the following: pathologic treatment response per CAP tumor regression grade 0,1,2, and 3, blood level measurement of protein CA 19-9 units/milliliter, and radiologic response by tumor measurements in mm and using RECIST tumor measurement categories of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) for all patients, and margin assessment (R0/R1 resection) in resected patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy or cytology proven adenocarcinoma of the pancreas * No clinical evidence of metastatic disease on imaging * Age 18 or older * Receiving chemotherapy for non-metastatic pancreatic cancer Exclusion Criteria: * Biopsy proven metastatic disease
References
Publications (0)
Data not yet available
No reference posted for this study.