Clinical trial NCT04579575: Added Value of O-RADS in Evaluation of Ovarian Lesions
Official title: Added Value of Ovarian-Adnexal Reporting and Data System in Evaluation of Ovarian Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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 .
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hisham Moustafa Kamel
role: STUDY_DIRECTOR
affiliation: South Egypt Cancer Institute ,Assiut University
name: Haisam Ahmed Samy Aly Atta
role: STUDY_DIRECTOR
affiliation: South Egypt Cancer Institute ,Assiut University
name: Doaa Mohamed Fouad
role: STUDY_DIRECTOR
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