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NCT Number: NCT06673121

Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location status: Recruiting

Location contact

Miao Zhou

CONTACT

[email protected]

13733829100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

traditional Chinese medicine

Drug

Received treatment with traditional Chinese medicine

Primary outcomes

  1. Pulmonary nodule growth

    Time frame: 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

  2. Pulmonary nodule regression

    Time frame: 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 outcomes

  1. Nodule stability

    Time frame: 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%

  2. Pulmonary nodule volume

    Time frame: 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

  3. Mean density of pulmonary nodules

    Time frame: 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

  4. Doubling time of pulmonary nodule volume

    Time frame: 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

  5. Internal signs of pulmonary nodules

    Time frame: 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

  6. External signs of pulmonary nodules

    Time frame: 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

  7. self-rating anxiety scale

    Time frame: 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

  8. self-rating depression scale

    Time frame: 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

  9. SF-36 scale

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Miao zhou

CONTACT

[email protected]

13733829100

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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