Clinical trial · Interventional
A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy
INFORM: A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liquid Biopsy for Early Screening of Lung Cancer | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liquid Biopsy Early Screening | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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.
- interventionNames
- Diagnostic Test: Liquid Biopsy Early Screening
- type
- NO_INTERVENTION
- label
- control group
- description
- 2972 individuals were enrolled from the general population for routine LDCT screening.
Primary outcomes (1)
- measure
- Positive Predictive Value
- timeFrame
- 2 years
- description
- When a test result indicates that a patient is positive, the probability that the true condition is positive.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWang 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