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

Validation of a miRNA Panel to Optimize Treatment Response in Patients With Metastatic Pancreatic Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Metastasis; Epigenetic

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• 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

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • A Beneficência Portuguesa de São Paulo
    • Contact: Bianca Verboski; Phone Number: +551135055031; Email: bianca.verboski@bp.org.br
    • Contact: Camila Farias; Phone Number: +551135054680; Email: camila.farias@bp.org.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with metastatic PDAC of both sexes, aged 18 years or older, who will start treatment with FOLFIRINOX at BP - A Beneficência Portuguesa de São Paulo.

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Non-responder; Patients who do not respond to the FOLFIRINOX regimen.
Responder; Patients who respond to the FOLFIRINOX regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Benedito Mauro Rossi

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: miRNA; Pancreatic cancer; Treatment response; Epigenetic; Folfirinox
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: mirPANC 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No