Cohort Study, Pulmonary Nodule, Traditional Chinese Medicine
Conditions
Keywords
Pulmonary nodule, Cohort study, Traditional Chinese Medicine
Brief summary
This study is a prospective multicenter cohort study that primarily evaluates the impact of traditional Chinese medicine treatment on pulmonary nodules
Detailed description
This study is a multicenter, prospective cohort study that will recruit at least 2244 individuals with chest HRCT findings of pulmonary nodules and recommended follow-up by MDT from four research centers. According to whether patients with pulmonary nodules are treated with traditional Chinese medicine, they are divided into a traditional Chinese medicine cohort and a non-traditional Chinese medicine cohort , and are followed up for at least 2 years. The main outcome measures were pulmonary nodule growth (enlargement or new onset) and nodule regression (reduction or disappearance). To evaluate the efficacy of traditional Chinese medicine treatment for patients with pulmonary nodules, secondary outcome measures include nodule volume, average nodule density, doubling time of volume, internal and external signs of nodules, anxiety self-assessment scale, depression self-assessment scale and SF-36 scale.
Interventions
DRUGTraditional Chinese Medicine
Received treatment with traditional Chinese medicine
Sponsors
Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
① Patients with pulmonary nodules and recommended for follow-up by MDT; ② Voluntarily sign the informed consent form.
Exclusion criteria
①Patients with metastatic pulmonary nodules; ②Patients with benign diseases such as pulmonary lymph nodes, hamartomas, sclerosing alveolar cell tumors, or nodules with obvious benign features such as calcification; ③Patients withserious heart, lung, liver and kidney diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary nodule growth | Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. | Enlargement of pulmonary nodules or appearance of new pulmonary nodules |
| Pulmonary nodule regression | Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. | Shrinkage or disappearance of pulmonary nodules |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean density of pulmonary nodules | Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. | Calculate through chest HRCT and AI analysis |
| Doubling time of pulmonary nodule volume | Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. | Through AI analysis and calculation |
| Internal signs of pulmonary nodules | Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. | The HRCT manifestations of pulmonary nodules include vacuolar sign, bronchial sign, cystic sign, microvascular sign, etc |
| Nodule stability | Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. | The volume change of pulmonary nodules is within ± 15% |
| self-rating anxiety scale | Scale will be measured at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. A score of 50-59 is defined as mild anxiety, and 60-69 is defined as moderate anxiety , and a score of 70 or above is defined as severe anxiety. | Evaluate the anxiety status of patients with pulmonary nodules |
| self-rating depression scale | Scale will be measured at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. A score of ≥ 53 indicates the presence of depression. | Evaluate the depression status of patients with pulmonary nodules |
| SF-36 scale | Scale will be measured at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.The scores in all aspects are from 0 to 100 points, and the higher the score, the better the quality of life. | Evaluate the quality of life of patients with pulmonary nodules |
| External signs of pulmonary nodules | Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. | The external features of pulmonary nodules include morphology, boundaries, margins, spicules, pleural traction, etc |
| Pulmonary nodule volume | Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60. | Calculate through chest HRCT and AI analysis |
Countries
China
Contacts
Primary ContactMiao zhou
Outcome results
None listed