| 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 |
|
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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 |
| 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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C56||Malignant neoplasm of ovary, |
|
|
Intervention / Comparator Agent
|
|
|
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
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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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. |