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

Phase

N/A

Condition

Digestive System Neoplasms

Pancreatic Cancer

Pancreatic Disorders

Treatment

Blood draw

Clinical Study ID

NCT04406831

15-10

Ages > 18
All Genders
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Have biopsy proven adenocarcinoma of the pancreas
Have initially inoperable disease, classified as either locally advanced or metastaticdisease
Recurrent disease after a Whipple procedure is allowed
Patients who are able to undergo resection after neoadjuvant therapy willcontinue 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

Exclusion Criteria:

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

Study Design

Blood draw

April 01, 2015

April 30, 2027

Study 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.

Connect with a study center

Nuvance Health
Norwalk, Connecticut 06856
United States
Active - Recruiting

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