Clinical trial NCT06422637: A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy
Official title: INFORM: A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liquid Biopsy for Early Screening of Lung Cancer
Keywords: Lung Cancer
Liquid Biopsy
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 5944
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Positive Predictive Value
timeFrame: 2 years
Secondary outcomes:
measure: Detection rate of non-stage 0 lung cancer within 2 years
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
Study officials:
affiliation: Department of Medical Oncology of Respiratory, Guangxi Medical University Cancer Hospital
name: Jianxing He, MD
role: PRINCIPAL_INVESTIGATOR
References: