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CTRI Number  CTRI/2022/06/043487 [Registered on: 24/06/2022] Trial Registered Prospectively
Last Modified On: 24/06/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   PLHIV-Lung Morbidity Cohort study ( Lung morbidity among people living with HIV) 
Scientific Title of Study   Assessing prevalence and risk of lung morbidities including lung nodules and cancer using non-contrast CT among PLHIV in Pune, India 
Trial Acronym  LMCS PLHIV 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohidas Borse  
Designation  Professor and Head of Department  
Affiliation  BJ Medical College and Sassoon General Hospitals 
Address  Department of Medicine BJ medical College and sassoon General Hospitals Jai Prakash Narayan Road Pune 411001 Maharashtra

Pune
MAHARASHTRA
411001
India 
Phone  9763201215  
Fax    
Email  borserohidas53@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidya Mave  
Designation  CRS leader  
Affiliation  BJ Medical College Clinical trial unit  
Address  BJ Medical college Clinical trial unit(BJMC-CTU) BJ Medical College and Sassoon General Hospital ENT Department Jai Prakash Narayan Road Pune

Pune
MAHARASHTRA
411001
India 
Phone  9503646148  
Fax    
Email  vidyamave@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishi Suryavanshi  
Designation  CRS Coordinator  
Affiliation  BJ Medical College Clinical Trial Unit  
Address  BJ Medical college Clinical trial unit(BJMC-CTU) BJ Medical College and Sassoon General Hospital ENT Department Jai Prakash Narayan Road Pune

Pune
MAHARASHTRA
411001
India 
Phone  9823248979  
Fax    
Email  nishisuryavanshi@hotmail.com  
 
Source of Monetary or Material Support  
National Institute of Health(NIH) Maryland 20892 USA 
 
Primary Sponsor  
Name  TREAT Asia amfAR The Foundation for AIDS Research through a grant from the US NIH 
Address  Thialand 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
BJ Government Medical College  BJMC Clinical Trial Unit ENT Department Sassoon General Hospital Jai Prakash Narayan Road Pune 411001 Maharashtra India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohidas Borse   BJ Medical College-JHU Clinical Trial Unit   BJMC-JHU Clinical Trial Unit ENT department BJ Medical College and Sassoon General Hospital Jai Prakash Narayan Road Pune 411001 Maharashtra India
Pune
MAHARASHTRA 		 9763201215

borserohidas53@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committe B J Medical College and Sassoon General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  a. Men, women, and transgender persons known to be PLHIV ≥18 years of age.
(Note: Participants must be able to show proof that they are living with HIV, either by having a unique treatment number associated with the BJGMC-SGH ART center or a government provided HIV treatment book. A separate HIV test will not be performed in the study)
b. Willingness to undergo at least one chest NCCT.
c. Ability of the participant to provide informed consent.
(Note: Illiterate participants will be enrolled based on local regulatory policies, with appropriate provisions for informed consent)
 
 
ExclusionCriteria 
Details  a. Unwillingness to undergo at least one chest NCCT.
b. Having undergone a computed tomography (CT) of any part of the body, positron emission tomography (PET) or interventional radiology procedure (coronary angiography, angioplasty, etc.) within one year prior to the anticipated enrollment date.
c. Men, women or transgender PLHIV with cognitive, hearing or language impairment.
d. Men, women or transgender persons with unknown HIV status.
e. Men, women or transgender PLHIV with a history of lung cancer or having received treatment for lung cancer in the past.
f. Pregnant women.
g. Inability/ Unwillingness to provide informed consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a. Prevalent cases of lung nodules
b. Incident cases of lung nodules 		 a. end of 4th year
b. end of 3rd year  
 
Secondary Outcome  
Outcome  TimePoints 
a. Overall prevalence of chronic obstructive pulmonary disease (COPD)
b. Incident cases of COPD
c. Overall prevalence of interstitial lung disease (ILD)
d. Overall prevalence of pulmonary hypertension (PH)
e. Overall incidence of PH
f. Diffusion lung capacity of carbon monoxide (DLCO)
g. Fractional excretion of nitric oxide (FENO)
 		 a.end of 4th year
b.end of the 4th year, accounting for time on follow-up
c. end of 4th year
d.end of 3rd year
e. end of 3rd year
f. 1st year, 2nd year
g. 1st year, 2nd year 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   04/07/2022 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Trial Yet to commence  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a Study for Assessing prevalence and risk of lung morbidities including lung nodules and cancer using non-contrast CT among PLHIV in Pune, India. The purpose of the study is is to Characterize the prevalance and risk of lung cancer using non-contrast computed tomography, and other pulmonary multimorbidity(chronic pulmonary diseases and pulmonary comorbidities among people living with HIV.  
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