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A Single-center Prospective Cohort Study for Pure Pulmonary Ground Glass Nodules in Women Preparing for Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596371
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Lung Cancer Other: pure pulmonary ground glass nodules in women preparing for pregnancy

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single-center Prospective Cohort Study for Pure Pulmonary Ground Glass Nodules in Women Preparing for Pregnancy
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Intervention Details:
  • Other: pure pulmonary ground glass nodules in women preparing for pregnancy
    pure pulmonary ground glass nodules in women preparing for pregnancy

Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline GGO diameter [ Time Frame: 6 months, 1year, 2 years, 3 years, 4 years and 5 years ]
    Changes from baseline GGO diameter

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pure pulmonary ground glass nodules in women preparing for pregnancy
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- receiving immunosuppressor or steriods receiving chemo- or radio- therapy can not receive regular follow-up

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596371


Contacts
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Contact: Qun Wang +86-64041990-2018 wang.qun@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 20032
Contact: Qun Wang    +86-64041990-2018    wang.qun@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
More Information
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04596371    
Other Study ID Numbers: B2019-335
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No