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CTRI Number  CTRI/2026/01/101379 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 13/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Studying the adnexal lesions using Ultrasound 
Scientific Title of Study   ASSESMENT OF ADNEXAL LESIONS USING ULTRASOUND BY O-RADS APPROACH. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Poptani 
Designation  Resident doctor 
Affiliation  Fortis Hospital Mulund 
Address  Mulund - Goregaon Link Rd Nahur West, Industrial Area, Bhandup West, Mulund West, Mumbai, Maharashtra 400078

Mumbai
MAHARASHTRA
400078
India 
Phone  7620129595  
Fax    
Email  milanpoptani2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Milan Poptani 
Designation  Resident doctor 
Affiliation  Fortis hospital mulund 
Address  Bhandup West, Mumbai -400078, Maharashtra india

Mumbai
MAHARASHTRA
400078
India 
Phone  7620129595  
Fax    
Email  milanpoptani2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Milan Poptani 
Designation  Resident Doctor 
Affiliation  Fortis hospital mulund 
Address  Bhandup West, Mumbai -400078, Maharashtra india

Mumbai
MAHARASHTRA
400078
India 
Phone  7620129595  
Fax    
Email  milanpoptani2000@gmail.com  
 
Source of Monetary or Material Support  
Fortis hospital limited, Mulund - Goregaon Link Rd Nahur West, Industrial Area, Bhandup West, Mulund West, Mumbai, Maharashtra 400078, India. 
 
Primary Sponsor  
Name  Fortis hospital limited 
Address  Mulund Goregaon Link Road,Bhandup west,Mumbai-400078, Maharashtra, India 
Type of Sponsor  Private hospital/clinic 
 
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 
Dr Milan Poptani  Department of radiology, Fortis hospital  Mulund Goregaon Link Road,Bhandup west, Mumbai-400078, Maharashtra, India
Mumbai
MAHARASHTRA 		 7620129595

milanpoptani2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Women with adnexal lesion on ultrasound study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  female with adnexal lesion on the ultrasound study 
 
ExclusionCriteria 
Details  pregnant women
unmarried women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study spectrum of Ultrasound imaging features of adnexal lesions using O-RADS approach.
 		 baseline , 3 months , 6 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate Intermediate & High risk cases with Histopathology reports & MRI
(wherever possible).
 		 baseline , 3 months , 6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/01/2026 
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)   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  

Title of my Study is "ASSESMENT OF ADNEXAL LESION USING ULTRASOUND BY O-RADS APPROACH"

 

Type of study: Prospective Observational study.


Patient age-group and diagnosis:  Women >18 years with adnexal lesions


Procedure of study:

Patients with provisional/ clinical diagnosis of adnexal lesion will be enrolled for the study. Details of the study will be explained to the subjects. Written, Informed consent will be obtained. A detailed menstrual, obstetric and medical history of each patient will be taken.Ultrasound-Pelvis will be performed using an Ultrasound machine at Fortis hospital, Mulund and following features like size, type, locularity, margins, number of papillary projections, Color score on Doppler in the lesions will be assessed, based on which O-RADS US category/score will be evaluated.

 

The above data will be analyzed for the complications, primary outcome, and secondary outcome 


Primary Outcome : Spectrum of Ultrasound imaging features of adnexal lesions using O-RADS approach.


Secondary Outcome: Histopathological/MRI correlation with Ultrasound findings.


Based on the outcome what type of analysis and data collection:

The duration of study will be from IEC approval date till 18 months and 52 no. of patients will be included in this study.


All the data will be noted down in a pre-designed study proforma.

After data collection, data entry will be done in Excel.

Data analysis will be done with the help of statistical software SPSS Version 25.0.

All the qualitative data will be represented in the form of frequency and percentage.

Quantitative data will be represented using Mean ± SD and Median & IQR (Interquartile range). 

Analysis of sensitivity, specificity, positive predictive value and negative predictive value will be done for Ultrasound versus clinical findings (biopsy/ surgery/histopathology).

A p-value < 0.05 was taken as level of significance. 

Accuracy and Descriptive statistical analysis will be carried out in the present study. Diagnostic statistics such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy will be used to find the correlation of Ultrasound with Histopathology (final diagnosis).

Comparison of proportions will be done using Fisher’s Exact test and association between two non-parametric variables will be done using Pearson Chi-square test. The final data will be presented in the form of tables and graphs.


Post Data analysis, Results obtained may be published in journal.

Patient Information Sheet will be provided to all patients. Patient Information Sheet will contain methodology, risks, and benefits of the study and before enrolling patients in the study, Informed Consent will be taken from them. No active intervention will be done by the Primary Investigator.

The study will be done after approval from Institutional Ethics Committee and registeration of the trail is granted

 
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