Actively Recruiting
Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule (RESEARCH-PN)
Led by Third Affiliated Hospital of Henan University of Traditional Chinese Medicine · Updated on 2024-11-04
5000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of traditional Chinese medicine on people with pulmonary nodules, which are small spots found in the lungs during chest scans. This prospective multicenter cohort study involves at least 2244 participants from four research centers who have pulmonary nodules detected by high-resolution chest CT scans and are recommended for follow-up by a multidisciplinary team. The study aims to understand how traditional Chinese medicine impacts the growth or shrinking of these nodules over time. Participants are divided into two groups based on whether they receive traditional Chinese medicine treatment or not. They will be followed for at least two years, and outcomes such as nodule growth, new nodule appearance, or regression are measured at various time points depending on nodule risk levels. Secondary measures include changes in nodule size, density, volume doubling time, internal and external nodule features, as well as assessments of anxiety, depression, and quality of life using standard scales. During the study, participants will undergo regular chest CT scans at scheduled intervals ranging from 3 months to 60 months depending on their nodule risk. They will also complete self-assessment scales for anxiety, depression, and quality of life at multiple time points. Researchers will track changes in the nodules and patients' mental well-being to evaluate the potential benefits of traditional Chinese medicine. The study is sponsored by the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine and is expected to continue until the end of 2029.
CONDITIONS
Brief Title
Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pulmonary nodules recommended for follow-up by a multidisciplinary team
- Voluntarily signed the informed consent form
You will not qualify if you...
- Patients with metastatic pulmonary nodules
- Patients with benign lung diseases such as pulmonary lymph nodes, hamartomas, or sclerosing alveolar cell tumors
- Patients with obvious benign nodules with features like calcification
- Patients with serious heart, lung, liver, or kidney diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 2 years
Participants with pulmonary nodules are observed over time with regular assessments to track nodule growth, regression, and other health indicators.
Visits occur at varying intervals depending on nodule risk level: Low risk at months 12, 24, 36, 48, and 60; Medium risk every 6 months from month 6 to 60; High risk every 3 months from month 3 to 60. Additional assessments for anxiety, depression, and quality of life occur at the same intervals.
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
M
Miao zhou
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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