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

NCT04406831 | Recruiting

• 1 other identifier: 15-10
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Pancreas; Cancer; Biomarker

Outcome Measures

Primary Outcomes (1)

• Analysis of miRNA profile

  Analyze the miRNA profiles present at each time point.

  Through study completion, up to 5 years

Secondary Outcomes (2)

• PCR miRNA validation

  Through study completion, up to 5 years

• miRNA PCR expression

  Through study completion, up to 5 years

Study Arms (2)

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

Blood draw PROCEDURE

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

Control; New Unresectable Pancreatic Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuvance Health: lead

Study Sites (1)

Nuvance Health

Norwalk, Connecticut, 06856, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum Samples

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Richard Frank, MD

  Nuvance Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pramila Krumholtz, RN

CONTACT

pramila.krumholtz@nuvancehealth.org

Tammy Lo, MSN

CONTACT

tammy.lo@nuvancehealth.org

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Research

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: April 1, 2015
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement

Locations

US (1)