A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy

Официальное название

INFORM: A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy

Обзор

This project aims to establish the MERCURY pilot screening program as part of the "Love Lung Project," employing a novel concept of lung cancer screening with the assistance of low-dose computer tomography (LDCT). By using clinical pathology as the gold standard, it will parallelly compare the performance (with a sensitivity of ≥90%) of the MERCURY early lung cancer screening model against the LDCT-only screening group within the "Love Lung Project." Ultimately, the objective is to reduce the proportion of overtreatment, achieve earlier staging, and extend patient survival, thus enhancing clinical value.

Подробное описание

This study is the first international prospective interventional study for lung cancer screening. It designates the "Love Lung Program" using Low-Dose Computed Tomography (LDCT) screening as the control group and the MERCURY screening group as the intervention group. Participants from the general population were enrolled and randomly assigned to either group in a 1:1 ratio. The MERCURY group plans to collect baseline peripheral blood samples from 2,972 individuals for whole genome sequencing (WGS) based on plasma circulating free DNA (cfDNA). This will facilitate a comprehensive analysis of the fragmentomics characteristics of cfDNA. Through the MERCURY early lung cancer screening model, individuals potentially at early stages of lung cancer will be identified. Those showing positive signs will subsequently undergo sequential LDCT to further confirm lung cancer status, eventually confirmed via surgery or pathology. To minimize ethical risks, the negative cases will receive additional LDCT after three months to further confirm their lung status. The control group under the "Love Lung Program" will follow standard LDCT screening procedures with the same number of participants; those with positive LDCT results will undergo clinical diagnosis, while those with negative results will only be followed up for lung status. Relying on the "Love Lung Program," the objective is to establish a new concept of lung cancer screening that precedes with MERCURY screening assisted by LDCT diagnostics.

Вмешательства

• Диагностический тест Liquid Biopsy Early Screening
  An early screening model for lung cancer aids in identifying individuals with early-stage lung cancer. Those with positive indications of lung cancer will subsequently undergo confirmatory clinical assessments using Low-Dose Computed Tomography (LDCT) in sequence. Ultimately, a definitive diagnosis of lung cancer is established through surgical and pathological examination.

Первичные конечные точки

• Positive Predictive Value [Срок оценки: 2 years]

Вторичные конечные точки (1)

• Detection rate of non-stage 0 lung cancer within 2 years [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Age greater than 40 years old and less than 75 years old, regardless of gender.
• Sign the informed consent form.

Критерии исключения

• Pregnant women;
• Individuals currently diagnosed with any tumors other than lung cancer, or who have a history of cancer;
• Those who have undergone LDCT/CT screening within the past 1-3 years;
• Individuals currently suffering from a febrile illness, or who have had an acute inflammatory disease episode requiring internal medicine treatment within the last 14 days prior to blood draw;
• Individuals who have taken corticosteroids orally or through intravenous injection within the 14 days prior to blood draw;
• Organ transplant recipients or those who have previously received a non-autologous (allogeneic) bone marrow or stem cell transplant;
• Individuals in poor health or not suitable for blood drawing;
• Any other clinically significant disease or condition considered by the researchers to potentially affect adherence to the protocol, impact the patient's ability to provide informed consent, or render the patient unsuitable for participation in the clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Скрининг

Центры проведения

Китай · 1 центр

• Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical C — Гуанчжоу

Публикации

• Wang R, Ye Z, Wang Q, Xu R, Feng Y, Zhao N, Yan Y, Zhao Y, Lu X, Zheng X, Zheng J, Deng H, Zhong R, Gao R, Li J, Liang W, He J, Liang H. Dynamic screening initiation using 16 plasma protein biomarkers with polygenic risk and PLCOm2012: a precision prevention framework for lung cancer. J Transl Med. 2025 Dec 23;24(1):218. doi: 10.1186/s12967-025-07468-1. PMID 41430273

Идентификаторы

NCT: NCT06422637 · ES-2024-025-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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