Clinical trial NCT02710565: Use of EBUS TBNA for Cell Culture as an Aid to Diagnose Lung Cancer and Lymphoma
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2016-03-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cell culture growth
timeFrame: upto 50 Weeks
Secondary outcomes:
measure: Diagnostic benefit
timeFrame: upto 50 Weeks
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon Hospital
state: Essex
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Mid and South Essex NHS Foundation Trust
name: Dipak Mukherjee, MRCP MBBS
role: PRINCIPAL_INVESTIGATOR
References: