SarcoidosisNCT02472808
A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method
A study testing cTBNA without ROSE, cTBNA with ROSE and EBUS-TBNA without ROSE in people with Sarcoidosis, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- cTBNA without ROSE, cTBNA with ROSE and EBUS-TBNA without ROSE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110016
Ashesh Dhungana, MD, 09953586175, asheshdhungana12@gmail.com
Randeep Guleria, DM, 09810184738, randeepg@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcoidosis
- Being tested
- cTBNA without ROSE, cTBNA with ROSE, EBUS-TBNA without ROSE, EBUS-TBNA with ROSE
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cTBNA without ROSEOther
Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
cTBNA with ROSEOther
Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
EBUS-TBNA without ROSEOther
Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
EBUS-TBNA with ROSEOther
Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
| Study group | Role | What they receive |
|---|---|---|
| cTBNA without ROSE | Other | Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy Receives: Other: cTBNA without ROSE |
| cTBNA with ROSE | Other | Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy Receives: Other: cTBNA with ROSE |
| EBUS-TBNA without ROSE | Other | Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy Receives: Other: EBUS-TBNA without ROSE |
| EBUS-TBNA with ROSE | Other | Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy Receives: Other: EBUS-TBNA with ROSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE
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
Measured: 6 months
Secondary outcomes (17)
Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients
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
Measured: 6 months
Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Positive predictive value of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Measured: 6 months
Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis
Measured: 6 months
Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Measured: 6 months
Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis
Measured: 6 months
Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ashesh Dhungana, All India Institute of Medical Sciences
- Investigators
- Ashesh Dhungana, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472808
- Sponsor's protocol ID
- DM Thesis
- Status last verified
- Jun 2015
- First submitted
- 7 Jun 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of EBUS-TBNA Versus Conventional TBNA With Rapid on Site Evaluation in the Diagnosis of Sarcoidosis: a Randomised Study
- ClinicalTrials.gov ID
- NCT02472808
- Acronym / sponsor ID
- DM Thesis
- Conditions
- Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cTBNA without ROSE | Other | Other: cTBNA without ROSEPatients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy |
| cTBNA with ROSE | Other | Other: cTBNA with ROSEPatients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy |
| EBUS-TBNA without ROSE | Other | Other: EBUS-TBNA without ROSEPatients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy |
| EBUS-TBNA with ROSE | Other | Other: EBUS-TBNA with ROSEPatients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cTBNA without ROSEPatients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy | Other | cTBNA without ROSE |
| cTBNA with ROSEPatients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy | Other | cTBNA with ROSE |
| EBUS-TBNA without ROSEPatients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy | Other | EBUS-TBNA without ROSE |
| EBUS-TBNA with ROSEPatients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy | Other | EBUS-TBNA with ROSE |
Primary outcome
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
17 secondary outcomes
Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients
Time frame: 6 months
Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 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
Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 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
Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis
Time frame: 6 months
Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Time frame: 6 months
Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis
Time frame: 6 months
Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashesh Dhungana, MD principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cTBNA without ROSE, cTBNA with ROSE and EBUS-TBNA without ROSE in people with Sarcoidosis, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashesh Dhungana, MD (00919953586175, asheshdhungana12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.