Progression of Untreated Pulmonary Ground Glass Opacity

October 26, 2018 updated by: Shanghai Zhongshan Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Clinic out patients of thoracic surgery.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pulmonary GGO
Patients with pulmonary GGO.
Other: No intercention
No intercention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline GGO diameter
Time Frame: 6 months, 1year, 2 years, 3 years, 4 years and 5 years
Changes from baseline GGO diameter
6 months, 1year, 2 years, 3 years, 4 years and 5 years
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.
6 months, 1year, 2 years, 3 years, 4 years and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2018

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

October 20, 2018

First Submitted That Met QC Criteria

October 26, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B2018-137R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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