Multiple Pulmonary NodulesNCT04192201
A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules
An observational study of Multiple Pulmonary Nodules, run by Tongji Hospital at 1 site in China.
Trial summary
The purpose of this study is to actively monitor patients with multiple pulmonary Ground-glass Nodules (GGNs), in order to provide evidence for multiple GGNs treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Pulmonary Nodules
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2019to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with multiple GGNs by chest CT scan in a hospital.
Who may be able to join
- Age greater than 18 years
- Have two or more GGNs on CT imaging
- Diameter of GGNs > 5mm and ≤ 3cm
- GGNs must be greater than half ground glass
Who cannot join
- patients who have a history of lung cancer
- patients who have undergone chemotherapy, radiotherapy or targeted therapy before surgery
- pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital
Wuhan, Hubei, 430030
Xiangning Fu, MD, +8613607150390, fuxn2006@aliyun.com
About this study
The purpose of this study is to actively monitor patients with multiple pulmonary Ground-glass Nodules (GGNs), in order to provide evidence for multiple GGNs treatment.
Read the detailed description
Multiple pulmonary GGNs are very commonly identified particularly as increasing numbers of CT scans are performed as part of routine lung cancer screening. At the same time, the ideal solution for these cases continues to be debated. This aim of this study is to learn more about the effects of multiple factors on outcome of multiple pulmonary GGNs, such as patients' clinical characteristics, CT features and different pathological types. Furthermore, the optimal timing of surgery and the effect of different surgical choices on the prognosis of patients with multiple GGNs will be investigated.
- Conditions
- Multiple Pulmonary Nodules
- Keywords
- Multiple Pulmonary Nodules, Lung Neoplasms
- Medical subject headings
- Multiple Pulmonary Nodules, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival [Time Frame: From date of the recruitment, assessed up to 60 months]
5-year overall survival
Measured: October 31, 2024
Secondary outcomes (2)
5-year Progression-Free-Survival [Time Frame: From date of the recruitment, assessed up to 60 months]
5-year Progression-Free-Survival
Measured: October 31, 2024
Recurrence-free survival [Time Frame: From date of the recruitment, assessed up to 60 months]
Recurrence-free survival
Measured: October 31, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start31 Dec 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192201
- Sponsor's protocol ID
- TJ-LC-02
- Status last verified
- Oct 2019
- First submitted
- 23 Sep 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules
- ClinicalTrials.gov ID
- NCT04192201
- Acronym / sponsor ID
- TJ-LC-02
- Conditions
- Multiple Pulmonary Nodules
- Keywords
- Multiple Pulmonary Nodules, Lung Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 31 Dec 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Dec 2019 (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.
The purpose of this study is to actively monitor patients with multiple pulmonary Ground-glass Nodules (GGNs), in order to provide evidence for multiple GGNs treatment.
Detailed description
Multiple pulmonary GGNs are very commonly identified particularly as increasing numbers of CT scans are performed as part of routine lung cancer screening. At the same time, the ideal solution for these cases continues to be debated. This aim of this study is to learn more about the effects of multiple factors on outcome of multiple pulmonary GGNs, such as patients' clinical characteristics, CT features and different pathological types. Furthermore, the optimal timing of surgery and the effect of different surgical choices on the prognosis of patients with multiple GGNs will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with multiple GGNs by chest CT scan in a hospital.
Key inclusion criteria (4 listed)
- Age greater than 18 years
- Have two or more GGNs on CT imaging
- Diameter of GGNs > 5mm and ≤ 3cm
- GGNs must be greater than half ground glass
Key exclusion criteria (3 listed)
- patients who have a history of lung cancer
- patients who have undergone chemotherapy, radiotherapy or targeted therapy before surgery
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
5-year overall survival [Time Frame: From date of the recruitment, assessed up to 60 months]
Time frame: October 31, 2024
5-year overall survival
2 secondary outcomes
5-year Progression-Free-Survival [Time Frame: From date of the recruitment, assessed up to 60 months]
Time frame: October 31, 2024
Recurrence-free survival [Time Frame: From date of the recruitment, assessed up to 60 months]
Time frame: October 31, 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Multiple Pulmonary Nodules, run by Tongji Hospital 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 4 inclusion and 3 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 10 Dec 2019. 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 Xiangning Fu, MD (+8613607150390, fuxn2006@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival [Time Frame: From date of the recruitment, assessed up to 60 months] (time frame: October 31, 2024). 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 10 Dec 2019.