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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-abdominal Ultrasound | Device | All patients will undergo trans- abdominal and trans-vaginal examination (The trans-abdominal US was performed for virgin patients or patients with large tumors that cannot be completely seen by the TV route) performed on the devices available in South Egypt Cancer Institute in supine position. The most important b-mode parameters (such as gain, frequency, number of foci and their depth, etc.) of the US machines were manually adjusted to obtain similar image impressions.
Histo-pathological findings and other modalities. |
|
| 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 . | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with ovarian lesions expected to visit Radiology Department at South Egypt Cancer Institute or Assiut University Hospitals
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Abdel Maged Mohamed | Contact | 01013703870 | +2 | mahmoudmaged94@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Hisham Moustafa Kamel | Assiut University | Study Director |
| Haisam Ahmed Samy Aly Atta | South Egypt Cancer Institute ,Assiut University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17433597 | Background | Liu J, Xu Y, Wang J. Ultrasonography, computed tomography and magnetic resonance imaging for diagnosis of ovarian carcinoma. Eur J Radiol. 2007 Jun;62(3):328-34. doi: 10.1016/j.ejrad.2007.02.040. Epub 2007 Apr 11. | |
| 20823748 | Background | Levine D, Brown DL, Andreotti RF, Benacerraf B, Benson CB, Brewster WR, Coleman B, DePriest P, Doubilet PM, Goldstein SR, Hamper UM, Hecht JL, Horrow M, Hur HC, Marnach M, Patel MD, Platt LD, Puscheck E, Smith-Bindman R; Society of Radiologists in Ultrasound. Management of asymptomatic ovarian and other adnexal cysts imaged at US Society of Radiologists in Ultrasound consensus conference statement. Ultrasound Q. 2010 Sep;26(3):121-31. doi: 10.1097/RUQ.0b013e3181f09099. |
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| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| ID | Term |
|---|---|
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Doaa Mohamed Fouad |
| South Egypt Cancer Institute ,Assiut University |
| Study Director |
| 11169340 | Background | Timmerman D, Valentin L, Bourne TH, Collins WP, Verrelst H, Vergote I; International Ovarian Tumor Analysis (IOTA) Group. Terms, definitions and measurements to describe the sonographic features of adnexal tumors: a consensus opinion from the International Ovarian Tumor Analysis (IOTA) Group. Ultrasound Obstet Gynecol. 2000 Oct;16(5):500-5. doi: 10.1046/j.1469-0705.2000.00287.x. No abstract available. |
| 26800772 | Background | Timmerman D, Van Calster B, Testa A, Savelli L, Fischerova D, Froyman W, Wynants L, Van Holsbeke C, Epstein E, Franchi D, Kaijser J, Czekierdowski A, Guerriero S, Fruscio R, Leone FPG, Rossi A, Landolfo C, Vergote I, Bourne T, Valentin L. Predicting the risk of malignancy in adnexal masses based on the Simple Rules from the International Ovarian Tumor Analysis group. Am J Obstet Gynecol. 2016 Apr;214(4):424-437. doi: 10.1016/j.ajog.2016.01.007. Epub 2016 Jan 19. |
| 25320247 | Background | Van Calster B, Van Hoorde K, Valentin L, Testa AC, Fischerova D, Van Holsbeke C, Savelli L, Franchi D, Epstein E, Kaijser J, Van Belle V, Czekierdowski A, Guerriero S, Fruscio R, Lanzani C, Scala F, Bourne T, Timmerman D; International Ovarian Tumour Analysis Group. Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study. BMJ. 2014 Oct 15;349:g5920. doi: 10.1136/bmj.g5920. |
| 22390753 | Background | Van Calster B, Timmerman D, Valentin L, McIndoe A, Ghaem-Maghami S, Testa AC, Vergote I, Bourne T. Triaging women with ovarian masses for surgery: observational diagnostic study to compare RCOG guidelines with an International Ovarian Tumour Analysis (IOTA) group protocol. BJOG. 2012 May;119(6):662-71. doi: 10.1111/j.1471-0528.2012.03297.x. Epub 2012 Mar 6. |
| 19244063 | Background | Amor F, Vaccaro H, Alcazar JL, Leon M, Craig JM, Martinez J. Gynecologic imaging reporting and data system: a new proposal for classifying adnexal masses on the basis of sonographic findings. J Ultrasound Med. 2009 Mar;28(3):285-91. doi: 10.7863/jum.2009.28.3.285. |
| 21465605 | Background | Amor F, Alcazar JL, Vaccaro H, Leon M, Iturra A. GI-RADS reporting system for ultrasound evaluation of adnexal masses in clinical practice: a prospective multicenter study. Ultrasound Obstet Gynecol. 2011 Oct;38(4):450-5. doi: 10.1002/uog.9012. |
| 24327552 | Background | Kaijser J, Sayasneh A, Van Hoorde K, Ghaem-Maghami S, Bourne T, Timmerman D, Van Calster B. Presurgical diagnosis of adnexal tumours using mathematical models and scoring systems: a systematic review and meta-analysis. Hum Reprod Update. 2014 May-Jun;20(3):449-62. doi: 10.1093/humupd/dmt059. Epub 2013 Dec 9. |
| 30149950 | Background | Andreotti RF, Timmerman D, Benacerraf BR, Bennett GL, Bourne T, Brown DL, Coleman BG, Frates MC, Froyman W, Goldstein SR, Hamper UM, Horrow MM, Hernanz-Schulman M, Reinhold C, Strachowski LM, Glanc P. Ovarian-Adnexal Reporting Lexicon for Ultrasound: A White Paper of the ACR Ovarian-Adnexal Reporting and Data System Committee. J Am Coll Radiol. 2018 Oct;15(10):1415-1429. doi: 10.1016/j.jacr.2018.07.004. Epub 2018 Aug 24. |
| 31687921 | Background | Andreotti RF, Timmerman D, Strachowski LM, Froyman W, Benacerraf BR, Bennett GL, Bourne T, Brown DL, Coleman BG, Frates MC, Goldstein SR, Hamper UM, Horrow MM, Hernanz-Schulman M, Reinhold C, Rose SL, Whitcomb BP, Wolfman WL, Glanc P. O-RADS US Risk Stratification and Management System: A Consensus Guideline from the ACR Ovarian-Adnexal Reporting and Data System Committee. Radiology. 2020 Jan;294(1):168-185. doi: 10.1148/radiol.2019191150. Epub 2019 Nov 5. |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |