NCT06673121

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Jan 2024Dec 2029

Study Start

First participant enrolled

January 3, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2029

Last Updated

November 4, 2024

Status Verified

September 1, 2024

Enrollment Period

5 years

First QC Date

September 26, 2024

Last Update Submit

November 1, 2024

Conditions

Pulmonary NoduleCohort StudyTraditional Chinese Medicine

Keywords

Pulmonary noduleCohort studyTraditional Chinese Medicine

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +4 more secondary outcomes

Study Arms (2)

Traditional Chinese Medicine Group

Patients with pulmonary nodules treated with traditional Chinese medicine

Drug: Traditional Chinese Medicine

Non-Traditional Chinese Medicine Treatment Group

Patients with pulmonary nodules have not received traditional Chinese medicine treatment

Interventions

Traditional Chinese MedicineDRUG

Received treatment with traditional Chinese medicine

Traditional Chinese Medicine Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with pulmonary nodules have no age or gender restrictions

You may qualify if:

  • ① Patients with pulmonary nodules and recommended for follow-up by MDT; ② Voluntarily sign the informed consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Interventions

Medicine, Chinese Traditional

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Study Officials

  • Jiansheng LI, Professor

    The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Miao zhou

CONTACT

13733829100k1956f31@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2024

First Posted

November 4, 2024

Study Start

January 3, 2024

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2029

Last Updated

November 4, 2024

Record last verified: 2024-09

Locations

CN(1)