Incident Lung NoduleLNICSNCT05441202
Lung Nodule Intervention Cohort Study
An observational study of Incident Lung Nodule, run by Chinese Chronic Respiratory Disease Research Network at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Incident Lung Nodule
- What is being tested?
- transdermal therapy
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any patient with incident lung nodule after health check up
Who may be able to join
- incident lung nodule patients
Who cannot join
- severe baseline conditions
Trial locations and contacts
1 site in 1 country.
Guangxi Li contact
China1 site, 1 recruiting
- Recruiting
Guang An Men Hospital
Beijing, Beijing Municipality, 100053
XIAOHONG LIU, MD
About this study
Official title: The Efficacy of Transdermal Therapy for Lung nodule---an Real Word Observational Study
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.
- Conditions
- Incident Lung Nodule
- Being tested
- transdermal therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdermal therapyDevice
transdermal therapy with Chinese medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
change of lung nodule size
change of lung nodule size before and after intervention
Measured: three months minimal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jan 2022
- Primary completion31 Jul 2022 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incident Lung NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chinese Chronic Respiratory Disease Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441202
- Sponsor's protocol ID
- LN002
- Acronym
- LNICS
- Status last verified
- Jan 2022
- First submitted
- 28 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transdermal Therapy for Lung nodule---an Real Word Observational Study
- ClinicalTrials.gov ID
- NCT05441202
- Acronym / sponsor ID
- LNICS / LN002
- Conditions
- Incident Lung Nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Chinese Chronic Respiratory Disease Research NetworkResearch network
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any patient with incident lung nodule after health check up
Key inclusion criteria (1 listed)
- incident lung nodule patients
Key exclusion criteria (1 listed)
- severe baseline conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transdermal therapytransdermal therapy with Chinese medicine | Device | – |
Primary outcome
change of lung nodule size
Time frame: three months minimal
change of lung nodule size before and after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guangxi Li contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incident Lung Nodule, run by Chinese Chronic Respiratory Disease Research Network at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiaohong liu, MD (+8618364166279, 18364166279@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of lung nodule size (time frame: three months minimal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.