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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Study sites: 14 to 15
    • Collaborators: 14 to 15
    v6
  2. Minor Study sites: 4 to 14
    • Collaborators: 4 to 14
    v5
  3. Minor Study sites: 3 to 4
    • Collaborators: 3 to 4
    v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Primary endpoint revised
    • Secondary endpoint revised
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
4,790 trials monitored
See 263 trials at risk
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.
Trial Details
NCT Number NCT06518655
Lead Sponsor ChromX Health
Collaborators: The First Affiliated Hospital of Guangzhou Medical University, First People's Hospital of Foshan, Sichuan Cancer Hospital and Research Institute, Liwan District Central Hospital, Shanghai Chest Hospital, Peking Union Medical College Hospital, Guangzhou Development Zone Hospital, Huangpu District Hongshan Street Community Health Service Center, Huangpu District Chinese Medicine Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, Huangpu District Jiufo Street Community Health Service Center, Huangpu District Xinlong Town Central Hospital, Huangpu District Yonghe Street Community Health Service Center, Huangpu District Lianhe Street Second Community Health Service Center, Renmin Hospital of Wuhan University
Conditions
(from sponsor)
Pulmonary Nodules, Multiple, Pulmonary Nodules, Solitary, Lung Cancer
Related terms Lung Neoplasms, Multiple Pulmonary Nodules, Solitary Pulmonary Nodule
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov