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NCT06518655Recruiting

Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath

Exploratory Study on the Identification of Benign and Malignant Pulmonary Nodules Using Volatile Organic Compounds in Human Exhaled Breath

Source: ClinicalTrials.gov · Last updated 24 Dec 2025

Brief summary (registry, in English)

The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) markers. This model aims to accurately differentiate benign from malignant nodules in individuals harboring pulmonary nodules. The primary objectives it strives to accomplish are: 1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in distinguishing benign and malignant pulmonary nodules. 2. To evaluate the diagnostic effectiveness of an AI model that employs exhaled breath VOC biomakers to identify specific types of malignant nodules, including lung adenocarcinoma, lung squamous cell carcinoma, and small cell lung cancer. 3. To explore and identify key characteristic VOCs combinations that are associated with EGFR site mutations in malignant nodules, further modeling and evaluating the classification performance. By utilizing this comprehensive approach, the study hopes to contribute significantly to early detection and accurate classification of pulmonary nodules, ultimately leading to improved patient care and treatment outcomes.

Status (registry)
Recruiting
Study type
Observational
Enrollment
3000 (estimated)
First submitted
19 Jul 2024
Start date
30 Jun 2024
Primary completion date
30 Dec 2026
Lead sponsor
ChromX Health
Diseases
Lung cancer
NCT number
NCT06518655

What you commit to

  • Study type: Observational
  • Planned participants: 3000
  • From 30 Jun 2024 to the primary completion date, 30 Dec 2026
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients are unable to determine the pathological diagnosis of pulmonary nodules after surgical resection or biopsy;
  • Patients who have undergone lung transplantation or lobectomy;

Other illness

  • Patients with recurrent lung cancer;
  • Individuals who currently or have a history of malignant tumors;
  • Patients in the acute phase of inflammation or in need of intensive care in the above selected disease groups;
  • Mental illness patients (such as severe dementia, schizophrenia, severe depression, manic depressive psychosis, etc.);
  • Confirmed HIV patients;
  • Patients or family members are unable to understand the conditions and objectives of this study.

Other

  • The maximum diameter of pulmonary nodules is greater than 30 mm;
  • Individuals with severe liver and kidney dysfunction;
  • Pregnant or lactating women;
  • The patient is unwilling or unable to personally sign the informed consent form.

Who the study is looking for

  • 18-80 years old;
  • Pulmonary nodules were detected through low-dose spiral CT, chest CT conventional scan, or high-resolution thin-layer CT examination, with a maximum diameter of 5-30 mm, including solid nodules and ground glass nodules;
  • Patients require pulmonary nodule resection to define the type of nodule pathology;
  • The Patients have not yet used any drugs for tumor treatment;
  • Patients and/or family members are able to understand the research protocol and are willing to participate in this study, providing written informed consent.

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
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BeijingChinaRecruiting
Sichuan Cancer Hospital
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ChengduChinaRecruiting
First People's Hospital of Foshan
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FoshanChinaRecruiting
Huangpu District Chinese Medicine Hospital
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GuangzhouChinaRecruiting
Huangpu District Jiufo Street Community Health Service Center
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GuangzhouChinaRecruiting
Huangpu District Xinlong Town Central Hospital
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GuangzhouChinaRecruiting
Huangpu District Lianhe Street Second Community Health Service Center
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GuangzhouChinaRecruiting
Huangpu District Yonghe Street Community Health Service Center
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GuangzhouChinaRecruiting
The First Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
Guangzhou Development Zone Hospital
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GuangzhouChinaRecruiting
Huangpu District Hongshan Street Community Health Service Center
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GuangzhouChinaRecruiting
Liwan District Central Hospital
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GuangzhouChinaRecruiting
The Fifth Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
Shanghai Chest Hospital
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ShanghaiChinaRecruiting
Renmin Hospital of Wuhan University
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WuhanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.