| 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
|
|
|
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
|
|
|
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. |