Clinical trial NCT06673121: Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule
Official title: Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule （RESEARCH-PN）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Nodule
Cohort Study
Traditional Chinese Medicine
Keywords: Pulmonary nodule
Cohort study
Traditional Chinese Medicine
Lead sponsor: Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pulmonary nodules have no age or gender restrictions

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary nodule growth
timeFrame: 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.
measure: Pulmonary nodule regression
timeFrame: 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.
Secondary outcomes:
measure: Nodule stability
timeFrame: 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.
measure: Pulmonary nodule volume
timeFrame: 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.
measure: Mean density of pulmonary nodules
timeFrame: 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.
measure: Doubling time of pulmonary nodule volume
timeFrame: 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.
measure: Internal signs of pulmonary nodules
timeFrame: 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.
measure: External signs of pulmonary nodules
timeFrame: 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.
measure: self-rating anxiety scale
timeFrame: 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.
measure: self-rating depression scale
timeFrame: 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.
measure: SF-36 scale
timeFrame: 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.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jiansheng LI, Professor
role: STUDY_CHAIR
References: