NCT04192201

Brief Summary

The purpose of this study is to actively monitor patients with multiple pulmonary Ground-glass Nodules (GGNs), in order to provide evidence for multiple GGNs 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 Dec 2019

Longer than P75 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

September 23, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

December 31, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 10, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

September 23, 2019

Last Update Submit

December 5, 2019

Conditions

Multiple Pulmonary Nodules

Keywords

Multiple Pulmonary NodulesLung Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 5-year overall survival [Time Frame: From date of the recruitment, assessed up to 60 months]

    5-year overall survival

    October 31, 2024

Secondary Outcomes (2)

  • 5-year Progression-Free-Survival [Time Frame: From date of the recruitment, assessed up to 60 months]

    October 31, 2024

  • Recurrence-free survival [Time Frame: From date of the recruitment, assessed up to 60 months]

    October 31, 2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were diagnosed with multiple GGNs by chest CT scan in a hospital.

You may qualify if:

  • Age greater than 18 years
  • Have two or more GGNs on CT imaging
  • Diameter of GGNs \> 5mm and ≤ 3cm
  • GGNs must be greater than half ground glass

You may not qualify if:

  • patients who have a history of lung cancer
  • patients who have undergone chemotherapy, radiotherapy or targeted therapy before surgery
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood or tissues of Multiple Pulmonary Nodules in a patient.

MeSH Terms

Conditions

Multiple Pulmonary NodulesLung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Xiangning Fu, MD

CONTACT

+8613607150390fuxn2006@aliyun.com

Study Design

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

Study Record Dates

First Submitted

September 23, 2019

First Posted

December 10, 2019

Study Start

December 31, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2024

Last Updated

December 10, 2019

Record last verified: 2019-10

Locations

CN(1)