Trial record 2 of 11 for:    DIPAK

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Basildon and Thurrock University Hospitals NHS Foundation Trust
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02710565
First received: March 7, 2016
Last updated: March 11, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention
Lung Cancer
Lymphoma
Non-small Cell Lung Cancer
Non-Hodgkin Lymphoma
Mediastinal Lymphadenopathy
Other: Cohort

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Cell culture growth [ Time Frame: upto 50 Weeks ] [ Designated as safety issue: No ]
    Are samples from EBUS TBNA suitable for cell culture?


Secondary Outcome Measures:
  • Diagnostic benefit [ Time Frame: upto 50 Weeks ] [ Designated as safety issue: No ]
    To ascertain the diagnostic benefit of EBUS TBNS for diagnosis of lymphoma in patients with isolated mediastinal lymphadenopathy.


Estimated Enrollment: 60
Study Start Date: February 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02710565

Contacts
Contact: Dipak Mukerjee, MRCP MBBS 01268 524900 dipak.mukherjee@btuh.nhs.uk
Contact: Carol L Alves, BSc MRes 01268 524900 ext 3599 carol.alves@btuh.nhs.uk

Locations
United Kingdom
Basildon and Thurrock University Hospitals NHS FT Recruiting
Basildon, Essex, United Kingdom, SS16 5NL
Contact: Carol L Alves, BSc, MRes    01268 529400 ext 3599    Carol.Alves@btuh.nhs.uk   
Contact: Syed Abbas, MRCP FCPS    01268 524900    Syed.Abbas@btuh.nhs.uk   
Principal Investigator: Dipak Mukherjee, MRCP MBBS         
Imperial College London Active, not recruiting
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Basildon and Thurrock University Hospitals NHS Foundation Trust
Imperial College London
Investigators
Principal Investigator: Dipak Mukherjee, MRCP MBBS Basildon and Thurrock University Hospitals NHS Foundation Trust
  More Information

Responsible Party: Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02710565     History of Changes
Other Study ID Numbers: B723 
Study First Received: March 7, 2016
Last Updated: March 11, 2016
Health Authority: United Kingdom: Research Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:
Endo bronchial ultrasound
Trans bronchial needle aspiration
Cell line
Lung cancer

Additional relevant MeSH terms:
Lymphoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on July 25, 2016