Recruiting

MicroRNA

Sponsor:

Nuvance Health

Code:

NCT04406831

Conditions

Pancreatic Cancer Stage III

Pancreatic Cancer Stage IV

Pancreatic Ductal Adenocarcinoma

Pancreatic Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Blood draw

Study Details

Brief 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.

Conditions

Pancreatic Cancer Stage III

Pancreatic Cancer Stage IV

Pancreatic Ductal Adenocarcinoma

Pancreatic Neoplasms

Study ID

NCT04406831

Start date

Apr, 2015

Status verified date

Apr, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

New Unresectable Pancreatic Cancer

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

Control

Healthy individuals without cancer diagnoses to provide reference microRNA

Interventions

Blood draw

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

Primary outcome measure

  • Analysis of miRNA profile [ Time Frame: Through study completion, up to 5 years ]

Central Contacts and Locations

Central contacts

Pramila Krumholtz, RN

pramila.krumholtz@nuvancehealth.org

Tammy Lo, MSN

tammy.lo@nuvancehealth.org

Locations

Nuvance Health

Recruiting

Norwalk, Connecticut, United States, 06856

Contacts

Tammy Lo, APRN

203-855-3551Tammy.Lo@nuvancehealth.org

Principal Investigator:

Richard Frank, MD

More Information

Sponsor

Nuvance Health

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Pancreas
  • Cancer
  • Biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Nuvance Health on 2026-04-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.