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CTRI Number  CTRI/2024/11/076528 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 26/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   COMPARISON OF ENDOBRONCHIAL ULTRASOUND AND PET-CT WITH SURGICAL HISTOPATHOLOGY IN NODAL STAGING OF NON-SMALL CELL LUNG CANCER IN PATIENTS UNDERGOING SURGERY 
Scientific Title of Study   COMPARISON OF PET-CT AND ENDOBRONCHIAL ULTRASOUND WITH SURGICAL HISTOPATHOLOGY FOR MEDIASTINAL NODAL STAGING OF NON-SMALL CELL LUNG CANCER IN PATIENTS UNDERGOING SURGERY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaon Das 
Designation  Senior Resident 
Affiliation  AIIMS , New Delhi  
Address  Department of Surgical Oncology, Second floor, IRCH, All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – 110029 (India)

South West
DELHI
110029
India 
Phone  9647507267  
Fax    
Email  das.shaon17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sunil Kumar 
Designation  Professor 
Affiliation  AIIMS , New Delhi  
Address  Department of Surgical Oncology, Second floor, IRCH, AIIMS, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029

South West
DELHI
110029
India 
Phone  9968300241  
Fax    
Email  dr_sunilk@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Shaon Das 
Designation  Senior Resident 
Affiliation  AIIMS , New Delhi  
Address  Department of Surgical Oncology, Second floor, IRCH, All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – 110029 (India)

South West
DELHI
110029
India 
Phone  9647507267  
Fax    
Email  das.shaon17@gmail.com  
 
Source of Monetary or Material Support  
Department of Surgical Oncology, Second floor, IRCH, All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – 110029 (India) 
 
Primary Sponsor  
Name  AIIMS New Delhi  
Address  Department of Surgical Oncology, Second floor, IRCH, All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – 110029 (India) 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shaon Das  AIIMS, New Delhi  Department of Surgical Oncology, Second floor, IRCH, All India Institute of Medical Sciences (AIIMS) · Ansari Nagar · New Delhi – 110029 (India)
New Delhi
DELHI 
9647507267

das.shaon17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institue Ethics Committee for Post Graduate Research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C399||Malignant neoplasm of lower respiratory tract, part unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endobronchial USG  As Per protocol, every patient of carcinoma lung undergoes EBUS, for mediastinal nodal staging 
Comparator Agent  Histopathological analysis  All patients of carcinoma lung in this trial will undergo resection with mediastinal nodal staging surgically. 
Intervention  PET-CT  As per protocol, every carcinoma of lung patient undergoes PET-CT for metastatic workup 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All NSCLC lung undergoing surgery after mediastinal nodal evaluation 
 
ExclusionCriteria 
Details  1. Small cell lung cancer
2. Metastatic NSCLC
3. Dual primary malignancy
4. Recurrent NSCLC
5. Not giving consent for PETCT, EBUS-TBNA, or surgery
6. Received partial treatment outside AIIMS 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the diagnostic accuracies of PET-CT,EBUS compared to surgical histopathology for mediastinal nodal staging of NSCLC. Surgical histopathology will be taken as gold standard.  at time of post op HPE analysis 
 
Secondary Outcome  
Outcome  TimePoints 
To find out and compare the sensitivity, specificity, positive predictive value, and negative predictive value of PET-CT, EBUS . Surgical histopathology will be taken as gold standard  2 years 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   11/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Lung cancer is the leading cause of cancer (globally) incidence and mortality, accounting for an estimated 2 million diagnoses and 1.8 million deaths and also leading cause of cancer mortality worldwide.
 After initial diagnosis of NSCLC patients undergo for staging with PETCT as the treatment of NSCLC depending on the stage of the disease includes surgical resection with curative intent in early-stage disease and chemoradiation in advanced stage disease. For surgically resect-able cases EBUS is done to stage mediastinum to exclude mediastinal lymph-nodal involvement because for N2 disease there are two options of treatment either definitive chemo-radiation or NACT/NACTRT followed by assessment and surgery for selected patients. For mediastinal staging both the above mentioned tests have its own drawbacks. Studies show when both tests are  used together , a better staging of mediastinum is followed. As EBUS-TBNA may identify additional malignant LNs (7.4%), and this highlights the risk for false-negative findings with PET scanning in isolation. Also there are stations (like station 5/6/8/9) where EBUS cant sample.
 The study aims to see the accuracies of PET-CT and EBUS  when they are compared to post-surgical histopathological examination report. Thus this study will provide sensitivity, specificity , positive and negative predictive value of both the tests and how these tests contribute to proper mediastinal staging.
 
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