Use of EBUS TBNA for Cell Culture as an Aid to Diagnose Lung Cancer and Lymphoma

Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710565
• Other study ID #: B723
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2020
• Source: Mid and South Essex NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Male or females aged >18 years

2. Completed Chest CT

3. Written informed consent

Exclusion criteria

1. Patients with active tuberculosis (TB)

2. Pregnancy

3. Patients with significant psychiatric and or neurological comorbidity

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Lymphadenopathy
• Lymphoma
• Mediastinal Lymphadenopathy
• Non-Hodgkin Lymphoma
• Non-small Cell Lung Cancer

Intervention

Other:
• Cohort
Obtaining additional EBUS TBNA samples for cell culture

Locations

Country	Name	City	State
United Kingdom	Basildon Hospital	Basildon	Essex
United Kingdom	Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust	Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell culture growth	Are samples from EBUS TBNA suitable for cell culture?	upto 50 Weeks
Secondary	Diagnostic benefit	To ascertain the diagnostic benefit of EBUS TBNS for diagnosis of lymphoma in patients with isolated mediastinal lymphadenopathy.	upto 50 Weeks