NCT03132883

Brief Summary

New indications for bronchial echo-endoscopies with transbronchial needle aspiration (EBUS-PTBA) have appeared since the first French centers with this technique were fitted. Evaluate the respective share of each indication of EBUS-AWPB over time over the period 2008 - 2013

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,036

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

April 14, 2017

Last Update Submit

July 31, 2018

Conditions

Transbronchial SurgeryLymph Node Disease

Outcome Measures

Primary Outcomes (1)

  • Analysis of endoscopic examination (EBUS-PTBA): analysis of diagnosis and / or staging of bronchial carcinoma, diagnosis of sarcoidosis, tuberculosis, lymphoma, staging of extra-thoracic tumors

    Analysis of endoscopic examination (EBUS-PTBA): analysis of diagnosis and / or staging of bronchial carcinoma, diagnosis of sarcoidosis, tuberculosis, lymphoma, staging of extra-thoracic tumors

    5 years

Eligibility Criteria

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

Inclusive patients will be made from the computer database of endoscopy services of each of the 2 centers listing endoscopic examinations carried out over the period of interest

You may qualify if:

  • Patients who underwent a first linear echo-endoscopy at the CHU of Amiens and the CH of Saint-Quentin between January 2008 and December 2013

You may not qualify if:

  • Patient sent by a center outside Picardie
  • Patient having expressed a refusal to participate in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Study Officials

  • Damien BASILLE, Dr

    CHU AMIENS PICARDIE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 28, 2017

Study Start

February 1, 2017

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

August 2, 2018

Record last verified: 2018-07

Locations

FR(1)