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

NCT ID: NCT06422637

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5944 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-12-31

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.

Conditions

Liquid Biopsy for Early Screening of Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

By collecting 2,972 peripheral blood samples from a natural population baseline, a comprehensive analysis of the fragmentomic characteristics of cfDNA was conducted based on whole-genome sequencing (WGS) of plasma cfDNA.

Group Type: EXPERIMENTAL

Liquid Biopsy Early Screening

Intervention Type: DIAGNOSTIC_TEST

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.

control group

2972 individuals were enrolled from the general population for routine LDCT screening.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jianxing He

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianxing He, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology of Respiratory, Guangxi Medical University Cancer Hospital

Locations

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Jianxing He, MD

Role: CONTACT

drjianxing.he@gmail.com

86-20-83337792

Other Identifiers

ES-2024-025-02

Identifier Type: -

Identifier Source: org_study_id