The Role Of MicroRNA In The Diagnosis, Prognosis And Response To Treatment In Pancreatic Cancer

Study Overview

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

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.

Specific aims of the study include: 1. To obtain serum samples from patients with newly diagnosed pancreatic cancer at baseline before treatment and monthly throughout treatment. 2. To analyze the miRNA profiles present at each time point. 3. To determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test. 4. To determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.

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

PROCEDURE: Blood draw

15-10

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-05-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-29
First Submitted that Met QC Criteria 2020-05-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-01
First Posted (ACTUAL) 2020-05-28	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: New Unresectable Pancreatic Cancer Individuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease	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
: Control Healthy individuals without cancer diagnoses to provide reference microRNA	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

Participant Group/Arm

Intervention/Treatment

: New Unresectable Pancreatic Cancer

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

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

: Control

Healthy individuals without cancer diagnoses to provide reference microRNA

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	Measure Description	Time Frame
Analysis of miRNA profile	Analyze the miRNA profiles present at each time point.	Through study completion, up to 5 years

Secondary Outcome Measures	Measure Description	Time Frame
PCR miRNA validation	Determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.	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.	Through study completion, up to 5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pramila Krumholtz, RN

Phone Number:

Email: pramila.krumholtz@nuvancehealth.org

Study Contact Backup

Name: Tammy Lo, MSN

Phone Number:

Email: tammy.lo@nuvancehealth.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Richard Frank, MD, Nuvance Health

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record