Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule

Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule （RESEARCH-PN）

This study is a prospective multicenter cohort study that primarily evaluates the impact of traditional Chinese medicine treatment on pulmonary nodules

Study Overview

• Status: Recruiting
• Conditions: Cohort Study; Pulmonary Nodule; Traditional Chinese Medicine
• Intervention / Treatment: Drug: Traditional Chinese Medicine

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Miao Zhou; Phone Number: 13733829100; Email: k1956f31@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
      • Contact: Miao Zhou; Phone Number: 13733829100; Email: k1956f31@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with pulmonary nodules have no age or gender restrictions

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Traditional Chinese Medicine Group; Patients with pulmonary nodules treated with traditional Chinese medicine	Drug: Traditional Chinese Medicine; Received treatment with traditional Chinese medicine
Non-Traditional Chinese Medicine Treatment Group; Patients with pulmonary nodules have not received traditional Chinese medicine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary nodule growth	Enlargement of pulmonary nodules or appearance of new 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.
Pulmonary nodule regression	Shrinkage or disappearance 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nodule stability	The volume change of pulmonary nodules is within ± 15%	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.
Pulmonary nodule volume	Calculate through chest HRCT and AI analysis	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.
Mean density of pulmonary nodules	Calculate through chest HRCT and AI analysis	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.
Doubling time of pulmonary nodule volume	Through AI analysis and calculation	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.
Internal signs of pulmonary nodules	The HRCT manifestations of pulmonary nodules include vacuolar sign, bronchial sign, cystic sign, microvascular sign, etc	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.
External signs of pulmonary nodules	The external features of pulmonary nodules include morphology, boundaries, margins, spicules, pleural traction, etc	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.
self-rating anxiety scale	Evaluate the anxiety status of patients with pulmonary nodules	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.
self-rating depression scale	Evaluate the depression status of patients with pulmonary nodules	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.
SF-36 scale	Evaluate the quality of life of patients with pulmonary nodules	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.

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
• Investigators: Study Chair: Jiansheng LI, Professor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Cohort study; Traditional Chinese Medicine; Pulmonary nodule
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Respiratory Tract Diseases; Respiration Disorders; Multiple Pulmonary Nodules
• Other Study ID Numbers: RESEARCH-Pulmonary nodule

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No