NCT05441202

Brief Summary

Incident lung nodule is quite common in China. The major treatment method is long-term floolow up without a specific intervention. We aim to investigate the efficacy an safty of a novel transdermal therapy with Chinese herb. The study included two arms: one arm is routine treatment and another arm is routine treatment plus transdermal therapy. The study end point is the change of lung nodule size under CT scan.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 1, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

June 28, 2022

Last Update Submit

June 28, 2022

Conditions

Incident Lung Nodule

Outcome Measures

Primary Outcomes (1)

  • change of lung nodule size

    change of lung nodule size before and after intervention

    three months minimal

Interventions

transdermal therapyDEVICE

transdermal therapy with Chinese medicine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

any patient with incident lung nodule after health check up

You may qualify if:

  • incident lung nodule patients

You may not qualify if:

  • severe baseline conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang An Men Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

Central Study Contacts

xiaohong liu, MD

CONTACT

+861836416627918364166279@163.com

Guangxi Li

CONTACT

li.guangxi@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 1, 2022

Study Start

January 1, 2022

Primary Completion

July 31, 2022

Study Completion

January 1, 2025

Last Updated

July 1, 2022

Record last verified: 2022-01

Locations

CN(1)