An observational study in Lung Cancer, Small Cell Lung Cancer and Non-Small Cell Lung Cancer, sponsored by Creative Biosciences (Guangzhou) Co., Ltd.. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Creative Biosciences (Guangzhou) Co., Ltd. · Observational
The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose lung cancer by comparing with clinical standard method (includes chest CT examination or pathological examination).
In this clinical trial, the testing kit to be evaluated is a Human Multigene Methylation Detection Kit (Fluorescent PCR Method), which is intended to qualitatively detect methylation levels of multiple genes in human sputum specimen in vitro by Fluorescent PCR Method, and the standard method used in clinical diagnosis is chest CT examination or pathological examination.
Subjects will provided sputum specimen as required for the evaluation of the testing kit followed by a chest CT examination or pathological examination. Technical personnel who conduct the evaluation of the testing kit will remain blinded to the results of the clinical diagnosis by chest CT and/or pathological examination.
The results of the testing kit will be compared with the standard method, and the effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for lung cancer detection under normal clinical use will be assessed through statistical analysis.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's enrollment of 1,564 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Creative Biosciences (Guangzhou) Co., Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Subjects without age limit, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject must meet all three of the following criteria to be eligible for the study:
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Exclusion Criteria:
Any of the following conditions must be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting sputum specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) , eligible subjects also need to undergo the chest CT or pathological examination.
Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis · Procedure: chest CT or pathological examination
Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting sputum specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) , eligible subjects also need to undergo the chest CT or pathological examination.
Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis · Procedure: chest CT or pathological examination
Diagnostic Test: sputum specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)
Also known as: LUNSAFE
Subjects will undergo chest CT or pathological examination.
Sensitivity
Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
Time frame: One year
Specificity
Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
Time frame: One year
Consistency Rate
Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
Time frame: One year
Kappa Coefficient
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.
Time frame: One year
Plan to share: Undecided — Undecided We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Feb 2025, 35 months.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Creative Biosciences (Guangzhou) Co., Ltd.