NCT04596371

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 22, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

October 11, 2020

Last Update Submit

October 15, 2020

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline GGO diameter

    Changes from baseline GGO diameter

    6 months, 1year, 2 years, 3 years, 4 years and 5 years

  • Changes from baseline GGO CT index.

    Changes from baseline GGO CT index.

    6 months, 1year, 2 years, 3 years, 4 years and 5 years

Interventions

pure pulmonary ground glass nodules in women preparing for pregnancyOTHER

pure pulmonary ground glass nodules in women preparing for pregnancy

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pure pulmonary ground glass nodules in women preparing for pregnancy

You may qualify if:

  • \- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 20032, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Central Study Contacts

Qun Wang

CONTACT

+86-64041990-2018wang.qun@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2020

First Posted

October 22, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 22, 2020

Record last verified: 2020-01

Locations

CN(1)