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

NCT06945978 | Recruiting

• 1 other identifier: mirPANC 2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Metastasis; Epigenetic

Keywords

Pancreatic cancer; miRNA; Treatment response; Epigenetic; Folfirinox

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Non-responder

Patients who do not respond to the FOLFIRINOX regimen.

Responder

Patients who respond to the FOLFIRINOX regimen.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Benedito Mauro Rossi: lead

Study Sites (1)

A Beneficência Portuguesa de São Paulo

São Paulo, São Paulo, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

miRNA, plasma

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Camila Farias

CONTACT

+551135054680; camila.farias@bp.org.br

Bianca Verboski

CONTACT

+551135052639; bianca.verboski@bp.org.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgeon Oncologist

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 27, 2025
• Study Start: January 21, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)