Table 2.
Ongoing clinical trials investigating liquid biopsy non-coding RNA for lung cancer screening.
| Trial (ClinicalTrials.gov Identifier/ Name of Study) |
Intervention | Description | Posted Results |
|---|---|---|---|
| NCT02247453 (BIOMILD) | Spirometry, blood samples for miRNA profiling | Plasma microRNA Profiling as First Line Screening Test for Lung Cancer Detection: a Prospective Study | Yes |
| NCT04913155 (HANSE) | Blood samples | HANSE-Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort, Population-based Screening Study -Prospective, Randomized Comparator Controlled | No |
| NCT05452200 (ILYAD) | Spirometry, blood and breath samples | Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital | No |
| NCT02777996 (ITALUNG) | Blood and sputum samples | An Italian Randomized Trial for the Evaluation of the Efficacy of Lung Cancer Screening with Low Dose Computed Tomography | Yes |
|
NCT05494021 (CLUS 3.0) |
Blood samples | Lung Cancer Screening with Low-dose CT in China (CLUS Study) Version 3.0 | No |
| NCT00103363 | Sputum sample for cytology, spirometry, blood samples | Sputum Cytology in Screening Heavy Smokers for Lung Cancer | No |
|
NCT03975504 (CLUS 2.0) |
Blood samples | Community-based Lung Cancer Screening with Low-dose CT in China (CLUS Study) Version 2.0 | No |
| NCT05384769 | Liquid biopsy | Feasibility Study of Lung Cancer Screening Using Cell-Free DNA Liquid Biopsy at Home in High-Risk Current and Former Smokers | No |
| NCT00625690 | Blood samples | Development of a Lung Cancer-Screening Program at the University of Nebraska Medical Center: A Feasibility Study | No |
| NCT04968548 | Blood sample tested with Lung EpiCheck (Nucleix) | Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study | No |
|
NCT01687647 (AMORCE-CBP) |
Blood and sputum samples | Interest of Morphometric Analysis of Sputum Cytology for Lung Cancer Screening in Workers Highly Exposed to Asbestos-Exploratory Analysis of Biomarkers Predictive for Lung Cancer | No |
| NCT03452514 | Blood samples for miRNA profiling | Prospective Longitudinal Blinded Observational Diagnostic Study-Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT | No |
| NCT05174468 | Breath samples | Analysis of Volatile Chemicals in Lung Cancer Screen-Eligible Subjects Using Infrared Spectroscopy | No |
| NCT00301119 (NYULCBC) | Blood and sputum samples, urine, BAL, lung tissue, buccal swab | Lung Cancer Biomarkers and Screening | No |
|
NCT05306288 (DELFI-L201) |
Blood samples for ctDNA detection using a DELFI-based test | Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung | No |
| NCT04204499 (ASCENT) | Blood samples for DNA/RNA germline analysis, tumor surplus collected for WES and RNA profiling | Analysis of Screen-detected Lung Cancers’ Genomic Traits | No |
| NCT02500693 (AIR) | Blood samples for CTC analysis | Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients with Chronic Obstructive Pulmonary Disease | No |
| NCT02611570 | Blood samples, urine | Low Dose Computed Tomography Screening Study in Non-smokers with Risk Factors for Lung Cancer in Taiwan | No |
| NCT04315753 | Blood samples for CTC analysis, exosome antigens and cfDNA mutational analysis | Circulating and Imaging Biomarkers to Improve Lung Cancer Management and Early Detection | No |
| NCT04409444 (qUEST) | Blood sample for analysis of CTC, circulating nucleic acid, proteins and genetic variations (SNPs); nasal swab and brush samples for the identification of inflammatory markers | An Observational Cohort Study Investigating the Impact of Community-based Lung Cancer Screening Across a Deprived Geographical Area and the Role of Biomarkers for the Early Detection of Lung Cancer | No |
| NCT05432128 | Molecular typing early lung cancer, blood samples for peripheral blood ctDNA methylation testing | Molecular Typing System for Early Screening and Diagnosis of Lung Cancer Combined with Liquid Biopsy Technology | No |
| NCT00512746 | Blood samples and sputum samples for cytology and cytometry | A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group | No |
| NCT01475500 | Blood and sputum samples, urine, nasal washings, buccal epithelium, endobronchial tissue, and BAL | Nashville Early Diagnosis Lung Cancer Project | No |
| NCT00420862 (DANTE Trial) | Blood and sputum samples | A Randomized Study on Lung Cancer Screening with Low-Dose Spiral Computed Tomography | Yes |
| NCT02504697 (DECAMP-2) | Blood, sputum and airway samples, urine | Detection of Early Lung Cancer Among Military Personnel Study 2 (DECAMP-2): Screening of Patients with Early Stage Lung Cancer or at High Risk for Developing Lung Cancer | No |
| NCT00899262 (MEDLUNG) | Sputum samples and endobronchial biopsy tissue specimens | Biomarkers for Early Detection of Lung Cancer in Patients with Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers | No |
| NCT05164757 | Blood samples | New York Female Asian Nonsmoker Screening Study | No |
| NCT02837809 (MILD) | Blood samples for ctDNA detection and miRNA profiling | Early Lung Cancer Detection with Spiral Computed Tomography (CT), Positron Emission Tomography (PET) and Biomarkers: Randomized Trial in High Risk Individuals | Yes |
| NCT03628638 | Blood samples for protein and nucleic acids analysis | Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program | No |
| NCT03934866 (SUMMIT) | Blood samples for cfNA analysis | The SUMMIT Study: Cancer Screening Study with or Without Low Dose Lung CT to Validate a Multi-cancer Early Detection Test | No |
| NCT03499678 | Blood samples for the analysis of methylation changes in PBMC and ctDNA | Clinical Trials on Detection of Lung Cancer with Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells | No |
| NCT01982149 | Blood samples, urine, and airway epithelium | Incorporation of Genetic Expression of Airway Epithelium with CT Screening for Lung Cancer | No |
| NCT03181256 | Blood samples, sputum, urine, nasal and buccal epithelium | Early Detection of Lung Cancer in the Medically Underserved Population | No |
|
NCT04165564 (DECAMP 1 PLUS) |
Blood and airway samples | DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers | No |
| NCT04957433 | Blood and sputum samples | Lung Health Check Biomarker Study | No |
| NCT04558255 | Blood samples | Plasma Biomarkers as a Non-invasive Approach for Early Diagnosis of Lung Cancer | No |
|
NCT04323579 (CLEARLY) |
Blood samples for the analysis of CTs, miRNA signatures, exosome antigens and protein signatures | Validation of Multiparametric Models and Circulating and Imaging Biomarkers to Improve Lung Cancer EARLY Detection | No |
| NCT05462795 | Blood samples for DNA methylation analysis | Liquid Biopsy to Distinguish Malignant from Benign Pulmonary Nodules and to Monitor Response to Therapy | No |
| NCT03791034 | Blood samples for cfDNA analysis | Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer | No |
| NCT04216511 (ECLC) | Blood samples for the detection of tumor autoantibody | Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population | No |
| NCT03633006 | Blood samples | Blood Sample Collection in Subjects with Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer | No |
| NCT01925625 (ECLS) | Blood samples for autoantibodies detection using the EarlyCDT-Lung Test | Detection in Blood of Autoantibodies to Tumour Antigens as a Case-finding Method in Lung Cancer Using the EarlyCDT-Lung Test | No |
| NCT04825834 (DELFI-L101) | Blood samples for DNA based biomarkers analysis using the DELFI assay | DNA Evaluation of Fragments for Early Interception-Lung Cancer Training Study | No |
| NCT04156360 | Blood samples for the detection of CTCs and CAMLs | Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer | No |
| NCT04462185 | Blood samples and nasal epithelium | A Prospective Cohort Study of Chinese Patients with Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers | No |
| NCT03293433 | Blood samples for miRNA analysis | Quantification of microRNAs in Diagnosis of Pulmonary Nodules: Reproducibility Analysis of Intra- and Inter-observer and Inter-laboratory: Project miR-Nod | No |
| NCT03685669 | Blood samples for ctDNA methylation analysis | Detection of Early-stage Lung Cancer by Using Methylation Signatures in Circulating Tumor DNA | No |
|
NCT05227261 (K-DETEK) |
Blood samples for ctDNA analysis | Assessment of a Novel Blood Test in Early Detection of the Five Common Cancers Based on the Investigation of the Circulating Tumour DNA | No |
| NCT03181490 | Blood samples for ctDNA methylation profiles analysis | Multi-centers Validation of a Circulating Tumor DNA Assay to Differentiate Benign and Malignant Pulmonary Nodules Via Targeted High-throughput DNA Methylation Sequencing | No |
| NCT05415670 | Blood sample for whole-genome methylation sequencing | Development a Pulmonary Nodules Diagnosis Classification Model for Benign/Malignant of Bronchoscopic Biopsy Specimens Based on High-throughput Whole-genome Methylation Sequencing (GM-seq) | No |
| NCT03989219 | Blood samples for cfDNA methylation status analysis | Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule | No |
| NCT05724264 (SOLSTICE) | Blood samples for biomarker detection | SingapOre Lung Cancer Screening Through Integrating CT With Other biomarkErs | No |
| NCT05699213 | Blood samples for biomarker detection | A Pilot Study Evaluating the Feasibility of Novel MRI Sequences and Blood-Based Biomarkers for Discriminating Nodules Found During Lung Cancer Screening | No |
| NCT05766046(RISP) | Blood samples for miRNA analysis and biomarker detection | Early Diagnosis of Lung Cancer of the Italian Pulmonary Screening Network (RISP): Comparative Analysis for the Use of Low Dose Computed Tomography and Promotion of Primary Prevention Interventions in Subjects at High Risk for Lung Cancer | No |
|
NCT05649046 (PREVALUNG ETOILE) |
Blood samples and feces for microbiota analysis | Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE | No |