NCT04406831 · Nuvance Health
The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
What this study is about
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Analysis of miRNA profile
Time frame: Through study completion, up to 5 years
Analyze the miRNA profiles present at each time point.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Norwalk, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations