NCT03392506

Brief Summary

The purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign and malignant diagnosis.

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
120

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable lung-cancer

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

Study Start

First participant enrolled

November 28, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

November 29, 2017

Last Update Submit

January 1, 2018

Conditions

Lung Cancer

Keywords

CP-EBUSEBUS-TBNAReal time elasticityStaging of lung cancer

Outcome Measures

Primary Outcomes (1)

  • The effectiveness of EBUS-TBNA-RTE

    By comparison of the diagnostic accuracy of CT ,PET-CT and EBUS-TBNA-RTE

    1year

Study Arms (1)

EBUS-TBNA-RTE

EXPERIMENTAL

Patients do CT、 PETCT examination and EBUS-TBNA-RTE

Device: EBUS-TBNA-RTE

Interventions

EBUS-TBNA-RTEDEVICE

Every patient will do CT、 PETCT and EBUS-TBNA-RTE.These three kind of examination will have their own result.The three methods of inspection will be compared by diagnostic rate

EBUS-TBNA-RTE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intrathoracic lymph node enlargement
  • EBUS-TBNA operation can be performed

You may not qualify if:

  • \. Unable to cooperate with the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Xiaoxuan Zheng, MD

CONTACT

86-18918169140milozheng59@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director,Endoscopy Department,Shanghai Chest Hospital

Study Record Dates

First Submitted

November 29, 2017

First Posted

January 8, 2018

Study Start

November 28, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

CN(1)