跳至主要内容
临床试验/NCT06945978
NCT06945978招募中不适用

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

Benedito Mauro Rossi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Response to treatment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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;

排除标准

  • •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;

结局指标

主要结局

Response to treatment

时间窗: After the 8 cycle of therapy (each cycle is 15 days)

Response to FOLFIRINOX treatment after 8 cycles of therapy.

次要结局

未报告次要终点

研究者

发起方
Benedito Mauro Rossi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Benedito Mauro Rossi

Surgeon Oncologist

Beneficência Portuguesa de São Paulo

研究点 (1)

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