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

Not Applicable

Completed

• Conditions: Mediastinal Lymphadenopathy; Lung Cancer; Non-small Cell Lung Cancer; Lymphoma; Non-Hodgkin Lymphoma
• Interventions: Other: Cohort

• Registration Number: NCT02710565
• Lead Sponsor: Mid and South Essex NHS Foundation Trust

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-17
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	Cohort	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.

Primary Outcome Measures

Name	Time	Method
Cell culture growth	upto 50 Weeks	Are samples from EBUS TBNA suitable for cell culture?

Secondary Outcome Measures

Name	Time	Method
Diagnostic benefit	upto 50 Weeks	To ascertain the diagnostic benefit of EBUS TBNS for diagnosis of lymphoma in patients with isolated mediastinal lymphadenopathy.

Trial Locations

Locations (2)

Imperial College London; 🇬🇧 London, United Kingdom

Basildon Hospital; 🇬🇧 Basildon, Essex, United Kingdom