An observational study in Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV and Pancreatic Ductal Adenocarcinoma, sponsored by Nuvance Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Nuvance Health · Observational
Aberrant miRNA production has been linked to a wide range of human cancers and shown to play important roles in their genesis and growth. These miRNA can be detected in the blood and tumors of patients with cancer. The investigators hypothesize that the detection of certain miRNAs present in the blood/serum of patients with pancreatic cancer may be important to the early diagnosis of the disease. Furthermore, the investigators hypothesize that miRNA detection in PC patients will yield prognostic information and help predict the response to treatment.
Specific aims of the study include:
Individuals with new diagnoses of unresectable pancreatic cancer, or recurrent pancreatic cancer following a Whipple procedure
Have initially inoperable disease, classified as either locally advanced or metastatic disease
Exclusion Criteria:
Individuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease
Procedure: Blood draw
Healthy individuals without cancer diagnoses to provide reference microRNA
Procedure: Blood draw
Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw
Analysis of miRNA profile
Analyze the miRNA profiles present at each time point.
Time frame: Through study completion, up to 5 years
PCR miRNA validation
Determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
Time frame: Through study completion, up to 5 years
miRNA PCR expression
Determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.
Time frame: Through study completion, up to 5 years
Plan to share: Yes — De-identified participant data for all primary and secondary outcome measures will be made available
Supporting information: Study protocol, Icf, Csr
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