FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052553 [Registered on: 12/05/2023] Trial Registered Prospectively
Last Modified On: 10/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   How well do ultrasound scoring systems predict ovarian malignancies? 
Scientific Title of Study   Diagnostic Efficacy of Ultrasonographic Scoring Systems and Clinical Profile in differentiating Benign and Malignant Adnexal Masses 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GAURAV KHASTGIR 
Designation  JUNIOR RESIDENT 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Obstetrics & Gynaecology Nehru Hospital, 3rd Floor Postgraduate Institute of Medical Education & Research Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  9830456465  
Fax    
Email  gauravkhastgir1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SUJATA SIWATCH 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Postgraduate Institute of Medical Education & Research Chandigarh 
Address  Department of Obstetrics & Gynaecology Nehru Hospital, 3rd Floor Postgraduate Institute of Medical Education & Research Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  0172-2756331  
Fax    
Email  siwatch1@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  SUJATA SIWATCH 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Postgraduate Institute of Medical Education & Research Chandigarh 
Address  Department of Obstetrics & Gynaecology Nehru Hospital, 3rd Floor Postgraduate Institute of Medical Education & Research Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  0172-2756331  
Fax    
Email  siwatch1@yahoo.com  
 
Source of Monetary or Material Support  
Department of Obstetrics & Gynaecology Room No 10 Postgraduate Institute of Medical Education & Research Sector 12, Chandigarh 160012  
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education & Research Chandigarh 
Address  Sector 12 Chandigarh 160012 
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 
GAURAV KHASTGIR  Postgraduate Institute of Medical Education & Research  Department of Obstetrics and Gynaecology Room Number 10 Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH 
9830456465

gauravkhastgir1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, ostgraduate Institute of Medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C56||Malignant neoplasm of ovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  100 women presenting to Gynaecology OPD with Adnexal Masses 
 
ExclusionCriteria 
Details  1. Refusal to give consent
2. Women with follicular cysts and corpus luteal cysts <3 cm (O-RADS 1)
3. Women without pathological diagnosis and / or insufficient follow up
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Calculate the diagnostic accuracy of O-RADS Ultrasonographic scoring system to differentiate benign and malignant adnexal masses with pathological findings as reference standard  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of change in the radiological characteristics during follow-up USG of ORADS 2 lesions  1 year 
Diagnostic accuracy of other US Scoring systems i.e. RMI 4, IOTA SR and ADNEX Rules  1 year 
Identify descriptors of Adnexal masses on various US scoring systems and their association with different pathologies  1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/05/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Differential diagnosis of adnexal masses, especially those of ovarian origin, may be a challenge clinically and radiologically. Inconsistency while describing morphology of the lesion often results in significant differences in subsequent interpretations. The use of internationally agreed upon standardized systems help reduce inter observer variability in reports, thus increasing the probability of a correct diagnosis. Various prediction models have been developed to assist clinicians to determine the risk of malignancies in adnexal masses. This helps deciding the appropriate treatment strategy suited for the patient. Risk of Malignancy Index (RMI) was the first of such systems. Subsequently, other scoring systems including IOTA SR, IOTA LR, O-RADS, GI-RADS and most recently, the IOTA ADNEX score have been introduced. 

The available radiological scoring systems were established and tested based on data obtained from European populations. These systems need to be more widely validated in practice with various ethnic populations. Our study aims to compare the diagnostic efficacy of the O-RADS, IOTA SR, IOTA ADNEX rules for predicting benign and malignant ovarian tumours in the Indian population.

 
Close