Lung CancerNCT03723629
Progression of Untreated Pulmonary Ground Glass Opacity
An observational study of Lung Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
In this study, about 2000 GGO patients will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion and provide evidence for GGO treatment. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- No intercention
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2018to Jun 2022
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinic out patients of thoracic surgery.
Who may be able to join
- 35-80 years' old
- found pulmonary GGO with chest CT scan and CT follow-up after 3 months shows that the GGO remains
- Diameter of GGO > 5mm and < 3cm
- Solid component of GGO in pulmonary window < 5mm
- signed informed consent form
Who cannot join
- receiving immunosuppressor or steriods
- receiving chemo- or radio- therapy
- can not receive regular follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Qun Wang, +86-64041990-2018, wang.qun@zs-hospital.sh.cn
About this study
In this study, about 2000 GGO patients will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion and provide evidence for GGO treatment.
- Conditions
- Lung Cancer
- Being tested
- No intercention
- Keywords
- Ground glass opacity
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intercentionOther
No intercention
| Study group | Role | What they receive |
|---|---|---|
| pulmonary GGO | Patients with pulmonary GGO. Receives: Other: No intercention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline GGO diameter
Changes from baseline GGO diameter
Measured: 6 months, 1year, 2 years, 3 years, 4 years and 5 years
Changes from baseline GGO CT index.
Changes from baseline GGO CT index.
Measured: 6 months, 1year, 2 years, 3 years, 4 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start27 Jul 2018
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723629
- Sponsor's protocol ID
- B2018-137R
- Status last verified
- Oct 2018
- First submitted
- 20 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Untreated Pulmonary Ground Glass Opacity
- ClinicalTrials.gov ID
- NCT03723629
- Acronym / sponsor ID
- B2018-137R
- Conditions
- Lung Cancer
- Keywords
- Ground glass opacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 29 Oct 2018 (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.
In this study, about 2000 GGO patients will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion and provide evidence for GGO treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary GGO | – | Other: No intercentionPatients with pulmonary GGO. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic out patients of thoracic surgery.
Key inclusion criteria (5 listed)
- 35-80 years' old
- found pulmonary GGO with chest CT scan and CT follow-up after 3 months shows that the GGO remains
- Diameter of GGO > 5mm and < 3cm
- Solid component of GGO in pulmonary window < 5mm
- signed informed consent form
Key exclusion criteria (3 listed)
- receiving immunosuppressor or steriods
- receiving chemo- or radio- therapy
- can not receive regular follow-up
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 |
|---|---|---|
| No intercentionNo intercention | Other | pulmonary GGO |
Primary outcome
Changes from baseline GGO diameter
Time frame: 6 months, 1year, 2 years, 3 years, 4 years and 5 years
Changes from baseline GGO diameter
Changes from baseline GGO CT index.
Time frame: 6 months, 1year, 2 years, 3 years, 4 years and 5 years
Changes from baseline GGO CT index.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- 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 Lung Cancer, run by Shanghai Zhongshan 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 5 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 29 Oct 2018. 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 Qun Wang (+86-64041990-2018, wang.qun@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline GGO diameter (time frame: 6 months, 1year, 2 years, 3 years, 4 years and 5 years). The study lists 2 primary outcomes in all. 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 29 Oct 2018.