Use of EBUS TBNA for Cell Culture as an Aid to Diagnose Lung Cancer and Lymphoma (EBUS)
Primary Purpose
Lung Cancer, Lymphoma, Non-small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cohort
Sponsored by
About this trial
This is an interventional basic science trial for Lung Cancer focused on measuring Endo bronchial ultrasound, Trans bronchial needle aspiration, Cell line, Lung cancer
Eligibility Criteria
Inclusion criteria
- Male or females aged >18 years
- Completed Chest CT
- Written informed consent
Exclusion criteria
- Patients with active tuberculosis (TB)
- Pregnancy
- Patients with significant psychiatric and or neurological comorbidity
Sites / Locations
- Basildon Hospital
- Imperial College London
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cohort
Arm Description
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.
Outcomes
Primary Outcome Measures
Cell culture growth
Are samples from EBUS TBNA suitable for cell culture?
Secondary Outcome Measures
Diagnostic benefit
To ascertain the diagnostic benefit of EBUS TBNS for diagnosis of lymphoma in patients with isolated mediastinal lymphadenopathy.
Full Information
NCT ID
NCT02710565
First Posted
March 7, 2016
Last Updated
December 21, 2020
Sponsor
Mid and South Essex NHS Foundation Trust
Collaborators
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT02710565
Brief Title
Use of EBUS TBNA for Cell Culture as an Aid to Diagnose Lung Cancer and Lymphoma
Acronym
EBUS
Official Title
Use of Endo Bronchial Ultrasound (EBUS) Trans Bronchial Needle Aspiration (TBNA) for Cell Culture as an Aid to Diagnose Lung Cancer and Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mid and South Essex NHS Foundation Trust
Collaborators
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Obtaining adequate pathological specimen is essential in the diagnosis of cancer. Ultrasound guided sampling through endo bronchial ultrasound (EBUS) trans bronchial needle aspiration (TBNA) has emerged as a safe and accurate technique in the diagnosis and staging of lung cancer but subtyping and/or genotyping of TBNA samples obtained by convex probe EBUS has long been considered to be limited by the lack of tissue architecture in these small tissue samples. The performance of small tissue samples in non-small cell lung cancer (NSCLC) subtyping has been proven to be accurate in modern pathology practice adopting cell blocks and immunohistochemistry (IHC), reducing the NSCLC not otherwise specified rate for needle aspiration samples to 8-23%. It has also shown recently a promising result in work up of mediastinal lymphadenopathy when lymphoma is suspected.
It is thought that at times EBUS TBNA sample is still inadequate for further essential testing for diagnostic and therapeutic purpose and enhancing the yield is possibly by cell culture will not only be useful for diagnosing lung cancer and lymphoma but also will provide material for future research study.
We have therefore developed a research proposal in collaboration with scientists at the biomedical research laboratory at Imperial College London, who have excellent record in basic scientific research and currently involved in similar research on cell culture for other type of diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lymphoma, Non-small Cell Lung Cancer, Non-Hodgkin Lymphoma, Mediastinal Lymphadenopathy
Keywords
Endo bronchial ultrasound, Trans bronchial needle aspiration, Cell line, Lung cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cohort
Other Intervention Name(s)
EBUS TBNA
Intervention Description
Obtaining additional EBUS TBNA samples for cell culture
Primary Outcome Measure Information:
Title
Cell culture growth
Description
Are samples from EBUS TBNA suitable for cell culture?
Time Frame
upto 50 Weeks
Secondary Outcome Measure Information:
Title
Diagnostic benefit
Description
To ascertain the diagnostic benefit of EBUS TBNS for diagnosis of lymphoma in patients with isolated mediastinal lymphadenopathy.
Time Frame
upto 50 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Male or females aged >18 years
Completed Chest CT
Written informed consent
Exclusion criteria
Patients with active tuberculosis (TB)
Pregnancy
Patients with significant psychiatric and or neurological comorbidity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dipak Mukherjee, MRCP MBBS
Organizational Affiliation
Mid and South Essex NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Basildon Hospital
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Use of EBUS TBNA for Cell Culture as an Aid to Diagnose Lung Cancer and Lymphoma
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