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A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Subject must meet all three of the following criteria to be eligible for the study: 1.
Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form; 2. Who is willing to undergo or has completed chest CT and / or pathological examination within 3 months prior to enrollment; 3. Any subject who is current or former smoker with a history of smoking at least 30 packs per year, who has a history of smoking less than 15 years, and who has no history of pulmonary nodules or lung cancer. 4. Any subject who is required to meet any of the following conditions: 1. Who is diagnosed with or suspected of lung cancer, but without surgery, chemoradiotherapy, or targeted therapy; 2. Who has a history of smoking with at least 30 packs per year, and has quit smoking for less than 15 years, and has no history of pulmonary nodules or lung cancer; 3. Who has a long history of second-hand smoking or environmental lampblack inhalation, or a history of carcinogenic exposure in the workplace, or a history of tumors, or a family history of lung cancer in their immediate relatives, etc.; 4. Who has chronic cough with duration≥8 weeks; 5. Who has other interfering diseases, such as oral cancer, thyroid cancer, etc.

Exclusion Criteria:

  • - Subject with any of the following conditions shall be excluded: 1.
Who has a tracheotomy or has been seriously ill and already on a ventilator. 2. Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05337163
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Creative Biosciences (Guangzhou) Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lei Zheng, PhDLaiyu Liu, PhD
Principal Investigator Affiliation Nanfang Hospital of Southern Medccal UniversityNanfang Hospital of Southern Medccal University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma, Adenocarcinoma, Large Cell Carcinoma, Adenosquamous Carcinoma, Sarcomatoid Carcinoma, Respiratory Tract Infection, Acute Bronchitis, Pneumonia, Chronic Bronchitis, Chronic Obstructive Pulmonary Disease, Tuberculosis, Lung Neoplasm, Pulmonary Interstitial Fibrosis
Additional Details

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.

Arms & Interventions

Arms

: Lung cancer group

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.

: The normal group

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.

Interventions

Diagnostic Test: - Diagnostic Test: Sputum DNA methylation analysis

Diagnostic Test: sputum specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)

Procedure: - chest CT or pathological examination

Subjects will undergo chest CT or pathological examination.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangzhou, Guangdong, China

Status

Recruiting

Address

Nanfang Hospital of Southern Medccal University

Guangzhou, Guangdong,

Site Contact

Xiaoyun Chen

xianshuwang@creativebio.cn

+86-20-62786845

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