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NCT05432128

To Establish a Molecular Typing System for Early Diagnosis of Lung Cancer

Recruiting now Last updated 17 April 2024
What this trial tests

trial in Lung Cancer in 600 participants. Currently enrolling.

Timeline
1 January 2020
Primary endpoint
31 December 2025
31 December 2025

Quick facts

Lead sponsorSinglera Genomics Inc.
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment600
Start date1 January 2020
Primary completion31 December 2025
Estimated completion31 December 2025
Sites1 location across China

Conditions studied

Sponsor

Singlera Genomics Inc.

Who can join

Adults 18 to 75, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This topic to take large multicenter study real world, the advanced liquid biopsy will ctDNA methylation detection technique is applied to pulmonary nodules differential diagnosis and early lung cancer screening, validation of early lung cancer screening and diagnosis of molecular classification system model, the feasibility of the development of early lung cancer screening and diagnosis of molecular classification system, improve its early screening early detection accuracy and efficiency, Improve the survival status of lung cancer high-risk population. At the same time, this project combined AI analysis technology of LDCT image results with ctDNA methylation detection, so as to overcome false negatives caused by the deficiency of ctDNA methylation detection technology in sensitivity, specificity, stability and flux, and correct false positive results that may be caused by AI analysis technology of LDCT image results. The combination of the two can avoid missed diagnosis and over - examination and over - treatment.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cell-free DNA approaches for cancer early detection and interception.
    Medina JE, Dracopoli NC, Bach PB, Lau A, et al · · 2023 · cited 64× · PMID 37696619 · DOI 10.1136/jitc-2022-006013
  2. Screening for pancreatic cancer has the potential to save lives, but is it practical?
    Mazer BL, Lee JW, Roberts NJ, Chu LC, et al · · 2023 · cited 23× · PMID 37212770 · DOI 10.1080/17474124.2023.2217354
  3. Exploring the Potential of Non-Coding RNAs as Liquid Biopsy Biomarkers for Lung Cancer Screening: A Literature Review.
    Garbo E, Del Rio B, Ferrari G, Cani M, et al · · 2023 · cited 11× · PMID 37835468 · DOI 10.3390/cancers15194774
  4. Enhancing the differential diagnosis of small pulmonary nodules: a comprehensive model integrating plasma methylation, protein biomarkers, and LDCT imaging features.
    Yang M, Yu H, Feng H, Duan J, et al · · 2024 · cited 6× · PMID 39482707 · DOI 10.1186/s12967-024-05723-5
  5. Revolution of Circulating Tumor DNA: From Bench Innovations to Bedside Implementations.
    Yan X, Su J, Wang Z. · · 2025 · cited 1× · PMID 40699826 · DOI 10.3390/cimb47060428
  6. Genomic-Based Early Detection Screening: A Literature Review of Prospective Trials and Emerging Strategies for Gastrointestinal Cancers.
    Tizpa E, Sharzehi K, Nabavizadeh N. · · 2024 · PMID 39246640 · DOI 10.7759/cureus.68881

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Other recruiting trials for Lung Cancer

Currently open trials in the same condition.

Other Singlera Genomics Inc. trials

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