A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method

July 6, 2015 updated by: Dr. Ashesh Dhungana, All India Institute of Medical Sciences, New Delhi

Diagnostic Utility of EBUS-TBNA Versus Conventional TBNA With Rapid on Site Evaluation in the Diagnosis of Sarcoidosis: a Randomised Study

This trial compares the yield of cTBNA (conventional Transbronchial Needle Aspiration) versus the EBUS-TBNA (Endobronchial Ultrasound guided TBNA) for obtaining cytology when they are combined with endobronchial biopsy and transbronchial lung biopsy and rapid onsite examination (ROSE) of the obtained smears in the diagnosis of suspected sarcoidosis patients visiting our hospital for evaluation of mediastinal lymphadenopathy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is investigator initiated, prospective, unblinded randomized study comparing conventional TBNA with EBUS-TBNA for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis when combined with transbronchial lung biopsy and endobronchial biopsy. It will be conducted on 80 consecutive patients with suspected sarcoidosis presenting to Department of Pulmonary Medicine and Sleep Disorders in AIIMS (All India Institute of Medical Sciences), New Delhi. This study will help to know whether EBUS (Endobronchial Ultrasound guided) or conventional TBNA is better for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis. It will also help to know the value of adding rapid onsite evaluation of the cytology smears to both the procedures. It will also help to determine the overall yield of different procedures when they are combined for obtaining tissue samples for a diagnosis of sarcoidosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110016
        • Recruiting
        • All India Institute of Medical Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ashesh Dhungana, MD
        • Principal Investigator:
          • Randeep Guleria, DM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years and suspected Stage 1 (mediastinal or hilar Lymphadenopathy (LAP)) or Stage 2 ( LAP and parenchymal abnormalities) sarcoidosis
  • Significant mediastinal LAP (Short Axis Diameter more than 10mm)
  • Lymph Node (LN) enlargement in station 4, 7, 10 or 11 and CT chest findings consistent with sarcoidosis.
  • With or without supportive evidence of sarcoidosis - hypercalcemia, calciuria, raised ACE levels or restriction/obstruction on Pulmonary Function Tests (PFT).

Exclusion Criteria:

  • Obvious other organ involvement with possibility to confirm granuloma with minimally invasive diagnostic procedure (Skin biopsy, superficial lymph nodes, Lofgren's Syndrome)
  • Sarcoidosis Stage 3 and 4
  • Mediastinal Nodes less than 10 mm in short axis diameter
  • Absence of right paratracheal and subcarinal Lymph node enlargement more than 1 cm in short axis diameter
  • Those who received empiric Steroid for >2 weeks in preceding 3 months
  • Contraindication to bronchoscopy and TBNA (Coagulopathy, Hypoxemia)
  • Unwilling to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: cTBNA without ROSE
Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
Other: cTBNA without ROSE
Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
Other: cTBNA with ROSE
Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
Other: cTBNA with ROSE
Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Other: EBUS-TBNA without ROSE
Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
Other: EBUS-TBNA without ROSE
Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
Other: EBUS-TBNA with ROSE
Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
Other: EBUS-TBNA with ROSE
Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE
Time Frame: 6 months
Diagnostic Yield is defined as the number of patients with presence of non caseating granuloma on cytology smear divided by total number of sarcoidosis patient expressed as percentage
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients
Time Frame: 6 months
Yield is defined as the number of patients with presence of non caseating granuloma on cytology smear divided by total number of sarcoidosis patient expressed as percentage
6 months
Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Positive predictive value of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Sensitivity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Specificity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Positive predictive value of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Negative predictive value of endobronchial biopsy in the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Sensitivity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Specificity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Positive predictive value of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months
Negative predictive value of transbronchial lung biopsy in the diagnosis of Sarcoidosis
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
All India Institute of Medical Sciences, New Delhi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashesh Dhungana, MD, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DM Thesis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcoidosis

Clinical Trials on cTBNA without ROSE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings