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RecruitingNCT04406831Updated Apr 13, 2026

The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer

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

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Specific aims of the study include:

  1. To obtain serum samples from patients with newly diagnosed pancreatic cancer at baseline before treatment and monthly throughout treatment.
  2. To analyze the miRNA profiles present at each time point.
  3. To determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
  4. To determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.
02

Conditions studied

  • Pancreatic Cancer Stage III
  • Pancreatic Cancer Stage IV
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Neoplasms

Keywords

  • Pancreas
  • Cancer
  • Biomarker
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Individuals with new diagnoses of unresectable pancreatic cancer, or recurrent pancreatic cancer following a Whipple procedure

Inclusion criteria

  • Have biopsy proven adenocarcinoma of the pancreas
  • Have initially inoperable disease, classified as either locally advanced or metastatic disease

    • Recurrent disease after a Whipple procedure is allowed
    • Patients who are able to undergo resection after neoadjuvant therapy will continue to be followed after resection
  • Have radiographically measurable disease
  • Have an ECOG performance status of 2 or less
  • Be willing to contribute the required information and specimens
  • Provide written signed consent to participate

Exclusion criteria

Exclusion Criteria:

  • Having received prior anti-cancer treatments for metastatic pancreatic cancer
  • Concurrently receiving systemic therapy for another cancer except androgen deprivation therapy for stable/controlled prostate cancer
  • Presence of other active cancer except for: adequately treated local basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for >1 year prior to start of trial. Other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for > 5 years is allowable
04

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • New Unresectable Pancreatic Cancer

    Individuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease

    Procedure: Blood draw

  • Control

    Healthy individuals without cancer diagnoses to provide reference microRNA

    Procedure: Blood draw

Interventions

  • ProcedureBlood draw

    Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw

05

What researchers measure

Primary outcomes

  1. Analysis of miRNA profile

    Analyze the miRNA profiles present at each time point.

    Time frame: Through study completion, up to 5 years

Secondary outcomes

  1. 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

  2. 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

06

Study locations

1 of 1 sites recruiting
  • Nuvance Health
    Norwalk, Connecticut 06856, United States
    Recruiting
07

References and documents

Individual participant data

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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04406831
Lead sponsor
Nuvance Health
Responsible party
Richard Frank (Director of Cancer Research, Nuvance Health) — Principal investigator
First posted
May 28, 2020
Start date
Apr 2015
Primary completion
Apr 2030 (estimated)
Completion
Apr 2030 (estimated)
Last update
Apr 13, 2026

Study contacts

Pramila Krumholtz, RN
Contact
pramila.krumholtz@nuvancehealth.org
Tammy Lo, MSN
Contact
tammy.lo@nuvancehealth.org
Richard Frank, MD
principal investigator · Nuvance Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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