Validation Of A MiRNA Panel To Optimize Treatment Response In Patients With Metastatic Pancreatic Cancer (mirPANC 2)

Study Overview

Validation of a miRNA Panel to Optimize Treatment Response in Patients With Metastatic Pancreatic Cancer (mirPANC 2)

This study is being conducted to better understand how pancreatic cancer behaves during treatment and how we can improve methods for monitoring disease progression. The research aims to determine whether small molecules present in the blood, called miRNAs, can help doctors assess whether the treatment is working or needs adjustment. With this, we hope to make cancer monitoring less invasive and more precise, allowing patients to receive more personalized and effective treatments.

Pancreatic cancer, particularly Pancreatic Ductal Adenocarcinoma (PDAC), has an extremely poor prognosis, with a 5-year survival rate of less than 3% for advanced stages. In 2020, Brazil saw about 11,893 deaths from this condition, with incidence rates expected to rise. The standard treatment for metastatic PDAC is the FOLFIRINOX regimen, but its response is variable and its effectiveness is limited, with few advancements in personalized therapy and response prediction. This research aims to develop and validate a panel of serum-based miRNA biomarkers using qPCR and large-scale sequencing (NGS) to evaluate treatment response in metastatic PDAC patients. The goal is to identify miRNA expression patterns that predict the effectiveness of FOLFIRINOX and assist in personalizing treatment based on individual responses. The study will use liquid biopsy to collect blood samples and analyze circulating miRNAs, enabling early detection of treatment responses and disease progression. This will allow for precise therapeutic adjustments and alternative treatment options based on the patient's profile. The innovative approach combines liquid biopsy with miRNA analysis as a low-cost, effective tool for monitoring and personalizing treatment. Using qPCR, a more affordable method than NGS and microarrays, enhances clinical feasibility. The research is highly relevant to the Brazilian Unified Health System (SUS), as an accessible miRNA panel could optimize resource use, reduce costs of ineffective treatments, and improve care quality and outcomes, aligning with SUS's goals for precise and accessible healthcare.

Pancreatic Cancer
Metastasis
Epigenetic

mirPANC 2

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 2025-03-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-22
First Submitted that Met QC Criteria 2025-04-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-27
First Posted (ACTUAL) 2025-04-27	Results First Posted N/A	Last Verified 2025-04

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
: Non-responder Patients who do not respond to the FOLFIRINOX regimen.
: Responder Patients who respond to the FOLFIRINOX regimen.

Primary Outcome Measures	Measure Description	Time Frame
Response to treatment	Response to FOLFIRINOX treatment after 4 cycles of therapy.	After 4 cycle of therapy (each cycle is 15 days)
Response to treatment	Response to FOLFIRINOX treatment after 8 cycles of therapy.	After the 8 cycle of therapy (each cycle is 15 days)

Secondary Outcome Measures	Measure Description	Time Frame

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: Camila Farias

Phone Number: +551135054680

Email: camila.farias@bp.org.br

Study Contact Backup

Name: Bianca Verboski

Phone Number: +551135052639

Email: bianca.verboski@bp.org.br

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:

Patients diagnosed with metastatic PDAC;
Patients who will start treatment with FOLFIRINOX;
18 years or older;
Who agree to participate in the study by signing the Informed Consent Form;

Patients who have previously undergone chemotherapy, whether neoadjuvant, adjuvant, or any prior first-line treatment;
Patients who do not meet the minimum criteria to receive the proposed regimen, such as those with hyperbilirubinemia, those who are not candidates due to age or performance status deterioration;

Collaborators and Investigators

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

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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