Lung CancerNCT04596371
A Single-center Prospective Cohort Study for Pure Pulmonary Ground Glass Nodules in Women Preparing for Pregnancy
An observational study of Lung Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
In this study, about 200 pure GGO in women preparing for pregnancy will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion in women preparing for pregnancy and provide evidence for GGO treatment. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- pure pulmonary ground glass nodules in women preparing for pregnancy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Dec 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: pure pulmonary ground glass nodules in women preparing for pregnancy
Who may be able to join
- 20-45 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
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, 20032
Qun Wang, +86-64041990-2018, wang.qun@zs-hospital.sh.cn
About this study
In this study, about 200 pure GGO in women preparing for pregnancy will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion in women preparing for pregnancy and provide evidence for GGO treatment.
- Conditions
- Lung Cancer
- Being tested
- pure pulmonary ground glass nodules in women preparing for pregnancy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pure pulmonary ground glass nodules in women preparing for pregnancyOther
pure pulmonary ground glass nodules in women preparing for pregnancy
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 posted22 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 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
- 200 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
- NCT04596371
- Sponsor's protocol ID
- B2019-335
- Status last verified
- Jan 2020
- First submitted
- 11 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Prospective Cohort Study for Pure Pulmonary Ground Glass Nodules in Women Preparing for Pregnancy
- ClinicalTrials.gov ID
- NCT04596371
- Acronym / sponsor ID
- B2019-335
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Oct 2020 (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 200 pure GGO in women preparing for pregnancy will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion in women preparing for pregnancy and provide evidence for GGO treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pure pulmonary ground glass nodules in women preparing for pregnancy
Key inclusion criteria (1 listed)
- 20-45 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
Key exclusion criteria (1 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 |
|---|---|---|
| pure pulmonary ground glass nodules in women preparing for pregnancypure pulmonary ground glass nodules in women preparing for pregnancy | Other | – |
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 22 Oct 2020.
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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 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 22 Oct 2020. 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 22 Oct 2020; AzTrials last refreshed its copy on 1 Nov 2026.