NCT02710565

Brief Summary

Participants who are scheduled to have an endo bronchial ultrasound (EBUS) trans bronchial needle aspiration (TBNA) will provide additional samples. These samples will then be sent to Imperial College London to see whether a cell line can be grown. If growth is successful then the samples will be returned to our pathology department to see if grading is possible and then to compare these results with the previous diagnostic samples. The cell line samples will not be used for patient diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

2 active sites

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, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

March 7, 2016

Last Update Submit

December 21, 2020

Conditions

Keywords

Endo bronchial ultrasoundTrans bronchial needle aspirationCell lineLung cancer

Outcome Measures

Primary Outcomes (1)

  • Cell culture growth

    Are samples from EBUS TBNA suitable for cell culture?

    upto 50 Weeks

Secondary Outcomes (1)

  • Diagnostic benefit

    upto 50 Weeks

Study Arms (1)

Cohort

OTHER

Participants who are scheduled to have an endo bronchial ultrasound (EBUS) trans bronchial needle aspiration (TBNA) will provide additional samples. These samples will then be sent to Imperial College London to see whether a cell line can be grown. If growth is successful then the samples will be returned to our pathology department to see if grading is possible and then to compare these results with the previous diagnostic samples. The cell line samples will not be used for patient diagnosis.

Other: Cohort

Interventions

CohortOTHER

Obtaining additional EBUS TBNA samples for cell culture

Also known as: EBUS TBNA
Cohort

Eligibility Criteria

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

You may qualify if:

  • Male or females aged \>18 years
  • Completed Chest CT
  • Written informed consent

You may not qualify if:

  • Patients with active tuberculosis (TB)
  • Pregnancy
  • Patients with significant psychiatric and or neurological comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Basildon Hospital

Basildon, Essex, SS16 5NL, United Kingdom

Location

Imperial College London

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Lung NeoplasmsLymphomaCarcinoma, Non-Small-Cell LungLymphoma, Non-Hodgkin

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dipak Mukherjee, MRCP MBBS

    Mid and South Essex NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 17, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

December 23, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations