Added Value of O-RADS in Evaluation of Ovarian Lesions

December 14, 2021 updated by: Mahmoud Abdel Maged Mohamed, Assiut University

Added Value of Ovarian-Adnexal Reporting and Data System in Evaluation of Ovarian Lesions

To detect added value of O-RADS in evaluation of ovarian lesions and compare O-RADS with GI-RADS regarding malignancy rate, the validity and reliability through pathological results and other modalities

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ultrasound (US) continues to be the initial imaging modality of choice for the identification and characterization of adnexal masses (AM) . Structured reporting of AM findings was identified by a Society of Radiologists in Ultrasound consensus working group as a target for the investigation to improve the management of women with AM .

Many established guidelines and structured reporting have been developed using sonography to characterize AM, including subjective assessment, simple scoring systems, and statistically derived scoring systems .

In 2008, the International Ovarian Tumor Analysis (IOTA) group proposed the use of US simple rules for the diagnosis of ovarian malignancy. These are based on a set of five US features indicative for a benign tumor (B features), and five US features indicative for a malignant tumor (M features)

. In 2009, the Gynecology Imaging Reporting and Data System (GI-RADS) was designed as an attempt allowing standardized reporting of AM. This system is based on recognition patterns and criteria provided by the IOTA.

The American College of Radiology (ACR) published the Ovarian-Adnexal Reporting and Data System (O-RADS), which provides an up-to-date suggestion to stratify the AM according to sonographic features. The O-RADS offers a comprehensive algorithm that categorizes AM by their possibility of being normal (O-RADS 1), to high risk of malignancy (O-RADS 5) .

For the application of the US classification system of AM in clinical settings, it is essential to evaluate their validity and reproducibility. Several studies have investigated the validity of these risk stratification systems in the assessment of AM. However, data on the comparability and reproducibility of the systems are limited.

The purpose of this study is To detect added value of O-RADS in evaluation of ovarian lesions and compare O-RADS with GI-RADS regarding malignancy rate , the validity and reliability through pathological results.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with ovarian lesions expected to visit Radiology Department at South Egypt Cancer Institute or Assiut University Hospitals

Description

Inclusion Criteria:

  • All newly diagnosed patients with ovarian lesions referred to the radiology department.
  • Must be able to be examined.

Exclusion Criteria:

  • Patients younger than 17 years old
  • Patient who refused to be a part of the study and undergo examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Added value of Ovarian-Adnexal Reporting and Data System in evaluation of 30 participants with ovarian lesions regarding malignancy rate ,the validity and reliability after comparison with pathology specimens results .
Time Frame: Baseline
Evaluation of the ovarian lesions by Trans-abdominal and Trans-vaginal Ultrasound for diagnosis of ovarian malignancy as early as possible for further management
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Hisham Moustafa Kamel, Assiut University
  • Study Director: Haisam Ahmed Samy Aly Atta, south Egypt cancer institute ,Assiut university
  • Study Director: Doaa Mohamed Fouad, south Egypt cancer institute ,Assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 20, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O-RADS value in ovarian lesion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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