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CTRI Number  CTRI/2019/04/018753 [Registered on: 24/04/2019] Trial Registered Prospectively
Last Modified On: 04/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   CORRELATION OF BRONCHOSCOPIC AND RADIOLOGICAL FINDINGS IN SUSPECTED LUNG CANCER AND ITS OUTCOME 
Scientific Title of Study   CORRELATION OF BRONCHOSCOPIC AND RADIOLOGICAL FINDINGS IN SUSPECTED LUNG CANCER AND ITS OUTCOME- A CROSS SECTIONAL STUDY IN A TERTIARY CARE HOSPITAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arjun AS 
Designation  Junior Resident 
Affiliation  Ramaiah Medical College 
Address  Ramaiah Medical College M S R Nagar MSRIT Post Mathikere Bangalore 560054
Ramaiah Medical College M S R Nagar MSRIT Post Mathikere Bangalore 560054
Bangalore
KARNATAKA
560054
India 
Phone    
Fax    
Email  arjunlalu.2306@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gayathri Devi H J 
Designation  Professor and HoD 
Affiliation  MS Ramaiah Medical College 
Address  MS Ramaiah Medical College M S R Nagar MSRIT Post Mathikere Bangalore 560054
MS Ramaiah Medical College M S R Nagar MSRIT Post Mathikere Bangalore 560054
Bangalore
KARNATAKA
560054
India 
Phone    
Fax    
Email  gayathrijoshy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arjun AS 
Designation  Junior Resident 
Affiliation  Ramaiah Medical College 
Address  Ramaiah Medical College M S R Nagar MSRIT Post Mathikere Bangalore 560054
Ramaiah Medical College M S R Nagar MSRIT Post Mathikere Bangalore 560054
Bangalore
KARNATAKA
560054
India 
Phone    
Fax    
Email  arjunlalu.2306@gmail.com  
 
Source of Monetary or Material Support  
Department of Respiratory Medicine, Room No 6, ground floor, MS Ramaiah Memorial Hospital MSR nagar, MSR IT post, Mathikere, Bangalore -560054 
Department of Respiratory Medicine. Room No 28, Ground floor MS Ramaiah Medical College Hospital MSR nagar, MSR IT post, Mathikere, Bangalore-560054 (no monetory support) 
 
Primary Sponsor  
Name  Ramiah Medical College 
Address  MSR nagar, MSRIT post, Bnagalore 560054 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arjun AS  MS Ramaiah Medical College Hospital  Department of Respiratory Medicine, Room No 28, ground floor, MSR nagar, MSRIT post, Bangalore 560054
Bangalore
KARNATAKA 
7795077550

arjunlalu.2306@gmail.com 
Dr Arjun AS  MS Ramaiah Memorial hospital  Department of Respiratory Medicine, Room No 6, ground floor, MSR nagar MSR IT post, Mathikere, Bangalore 560054
Bangalore
KARNATAKA 
7795077550

arjunlalu.2306@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. clinical features suggestive of malignancy such as hemoptysis, unexplained weight loss, loss of appetite, unexplained persistent cough, hoarsnes of voice
2. Radiological features suggestive of lung malignancy
3.un explained and recurrent pleural effusion 
 
ExclusionCriteria 
Details  1. coagulopathy,
2. platelets < 50,000/dl
3. pulmonary hypertension
4. Recent myocardial infarction or unstable angina
5. inability to cooperate during the procedure. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Characterize Bronchoscopic findings in patients with Suspected Lung cancer and Correlate wit CT thorax and thereby asses positive predictive value  1 year 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To analyse the histopathological findings on biopsy  1 year 6 months 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   data collection not yet done  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Need for the study: Bronchoscopy and computed tomography of the thorax are the most common investigations utilized to screen and diagnose lung cancer. their individual utility in diagnosing lung cancer has been demonstrated by numerous studies. Studies correlating the two modalities in Indian setup are few. Hence this study will be done to analyze the bronchoscopy findings and the radiological correlation of suspected cases of lung malignancy at our tertiary care hospital, thus asses its positive predictive value.
objectives: 1. To characterize bronchoscopic findings in patients with suspected lung cancer and correlate with CT thorax  2. To analyse the histopathological findings on biopsy
Methodology: inclusion and exclusion criteria as mentioned
All patients with suspected lung carcinoma and for whom bronchoscopy is indicated, fiber optic bronchoscopy and biopsy will be done, their bronchoscopic findings will be noted. The patient will be followed up and the Histopathological examination and IHC reports will be noted. Bronchoscopic evaluation will be done by Respiratory medicine team, CT image findings will be reported by radiologists and histopathological examination will be done by pathologists at our tertiary care centre.
Statistical analysis: descriptive statistics of confirming lung carcinoma will be analyzed and summarized in terms of percentage and its 95% confidence interval will be estimated. The diagnostic yield of bronchoscopic biopsy will be done by validating with positive predictive value.
 
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