Pancreatic Cancer Stage IIINCT04406831
The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
An observational study of Pancreatic Cancer Stage III and Pancreatic Cancer Stage IV, run by Nuvance Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with new diagnoses of unresectable pancreatic cancer, or recurrent pancreatic cancer following a Whipple procedure
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pramila Krumholtz, RN contact
Tammy Lo, MSN contact
United States1 site, 1 recruiting
- Recruiting
Nuvance Health
Norwalk, Connecticut, 06856
Tammy Lo, APRN, 203-855-3551, Tammy.Lo@nuvancehealth.org
Richard Frank, MD
About this study
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:
- To obtain serum samples from patients with newly diagnosed pancreatic cancer at baseline before treatment and monthly throughout treatment.
- To analyze the miRNA profiles present at each time point.
- To determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
- To determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.
- Conditions
- Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV, Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasms
- Being tested
- Blood draw
- Keywords
- Pancreas, Cancer, Biomarker
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw
| Study group | Role | What they receive |
|---|---|---|
| New Unresectable Pancreatic Cancer | Individuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease Receives: Procedure: Blood draw | |
| Control | Healthy individuals without cancer diagnoses to provide reference microRNA Receives: Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of miRNA profile
Analyze the miRNA profiles present at each time point.
Measured: Through study completion, up to 5 years
Secondary outcomes (2)
PCR miRNA validation
Determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
Measured: 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.
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study startApr 2015
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuvance Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Frank, Nuvance Health
- Investigators
- Richard Frank, MD, Principal investigator, Nuvance Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406831
- Sponsor's protocol ID
- 15-10
- Status last verified
- Apr 2026
- First submitted
- 22 May 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04406831
- Acronym / sponsor ID
- 15-10
- Conditions
- Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV, Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasms
- Keywords
- Pancreas, Cancer, Biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nuvance HealthUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific aims of the study include:
- To obtain serum samples from patients with newly diagnosed pancreatic cancer at baseline before treatment and monthly throughout treatment.
- To analyze the miRNA profiles present at each time point.
- To determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
- To determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Unresectable Pancreatic Cancer | – | Procedure: Blood drawIndividuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease |
| Control | – | Procedure: Blood drawHealthy individuals without cancer diagnoses to provide reference microRNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with new diagnoses of unresectable pancreatic cancer, or recurrent pancreatic cancer following a Whipple procedure
Key inclusion criteria (8 listed)
- Have biopsy proven adenocarcinoma of the pancreas
- Have initially inoperable disease, classified as either locally advanced or metastatic disease
- Have radiographically measurable disease
- Have an ECOG performance status of 2 or less
- Be willing to contribute the required information and specimens
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawIndividuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw | Procedure or surgery | Control, New Unresectable Pancreatic Cancer |
Primary outcome
Analysis of miRNA profile
Time frame: Through study completion, up to 5 years
Analyze the miRNA profiles present at each time point.
2 secondary outcomes
PCR miRNA validation
Time frame: Through study completion, up to 5 years
miRNA PCR expression
Time frame: Through study completion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pramila Krumholtz, RN contact
Tammy Lo, MSN contact
Richard Frank, MD principal investigator
Nuvance Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer Stage III and Pancreatic Cancer Stage IV, run by Nuvance Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pramila Krumholtz, RN (pramila.krumholtz@nuvancehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of miRNA profile (time frame: Through study completion, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.