An observational study in NSCLC, sponsored by Guangzhou Institute of Respiratory Disease. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by Guangzhou Institute of Respiratory Disease · Observational
This study intends to use Onconscreen plus 520 Panel (Burning Rock, China) to conduct NGS testing in sputum, tissues and blood samples of patients with advanced NSCLC. In order to explore the use of sputum as a diagnosis method for NSCLC patients, we will collect relevant clinical information and follow-up treatment information. The primary endpoint will reveal the effectiveness, accuracy, and feasibility in sputum, as compared to tissues and blood samples. This study aims to study the feasibility and advantages/disadvantages of using sputum as an noval body fluid biopsy option.
With the advancements in the development of targeted therapy, the detection of actionable genes has become routine practice in diagnosing lung cancer, especially in non-small cell lung cancer (NSCLC). Due to its non-invasiveness and great accessibility, plasma-based mutation profiling, with a sensitivity of approximately 70% relative to tissue samples, is widely used in clinical settings. Profiling using other body fluids such as pleural effusion, ascites, cerebrospinal fluid have been actively explored. Circulating cell-free DNA has also been shown to be present in other bodily fluids such as sputum and urine, which have potential to serve as liquid biopsy media for comprehensive mutation profiling. In this study, we investigated the potential of sputum obtained from NSCLC patients for mutation profiling using matched tissue, plasma and sputum from more than 30 advanced-stage NSCLC patients.
Baseline tissues, plasma and sputum samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (tissue 1000X, sputum 1000X, plasma cfDNA 10000X), in different methods will be compared.
Primary endpoints:
1、Compare different sample types with concordence rate, sensitivity, and specificity.
Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Planning to enroll more than 30 newly diagnosed advanced NSCLC patients, age over 18 years old following the eligibility criteria.
Exclusion Criteria:
Sputum samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (sputum 1000X)
Diagnostic Test: Next generation sequencing
Clinical data review to obtain corresponding tissue samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (tissue 1000X)
Clinical data review to obtain corresponding plasma samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (plasma 10000X)
Extract DNA from sputum sample, minimum DNA amount should be over 50ng.
Compare different sample types with concordence rate, sensitivity, and specificity.
1. Concordance rate was defined as the fraction of the total number of true positive and true negative patients relative to the cohort or indicated subgroup; 2. Sensitivity rate means true positive rate, true positive patients were defined as those who carried at least one genomic alteration that were detected in both matched samples. 3. Specificity rate means ture negative rate, patients were as defined true negative if no alteration was detected from either matched sample.
Time frame: up to 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Guangzhou Institute of Respiratory Disease