Added Value of O-RADS in Evaluation of Ovarian Lesions

NCT04579575 | Unknown

• 1 other identifier: O-RADS value in ovarian lesion
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ovarian Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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. * The morphological features of each AM, and independently categorized the US images of each AM according to the O-RADS published by ACR and GI-RADS simple rules . The results of consensus reviewing were used to calculate the validity of each US classification system. * The definite diagnoses of AM were preferentially established based on Histo-pathological findings and other modalities.

Also known as: Trans-vaginal Ultrasound

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (11)

• 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.

  PMID: 17433597 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.

  PMID: 20823748 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.

  PMID: 11169340 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.

  PMID: 26800772 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.

  PMID: 25320247 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.

  PMID: 22390753 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.

  PMID: 19244063 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.

  PMID: 21465605 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.

  PMID: 24327552 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.

  PMID: 30149950 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.

  PMID: 31687921 BACKGROUND

MeSH Terms

Conditions

Ovarian Diseases

Condition Hierarchy (Ancestors)

Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

Mahmoud Abdel Maged Mohamed

CONTACT

01013703870; mahmoudmaged94@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 8, 2020
• Study Start: December 20, 2021
• Primary Completion: January 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12