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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596371
• Other study ID #: B2019-335
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Qun Wang
• Phone: +86-64041990-2018
• Email: wang.qun[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Other:
• pure pulmonary ground glass nodules in women preparing for pregnancy
pure pulmonary ground glass nodules in women preparing for pregnancy

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline GGO diameter	Changes from baseline GGO diameter	6 months, 1year, 2 years, 3 years, 4 years and 5 years
Primary	Changes from baseline GGO CT index.	Changes from baseline GGO CT index.	6 months, 1year, 2 years, 3 years, 4 years and 5 years