Gynacological Imaging Reporting and Data System in Ovarian Masses by Ultrasonography

NCT03175991 | Completed

• 1 other identifier: HAGAR098765
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian masses are common problems in clinical practice. Sonography is considered the firstline imaging technique for discriminating between malignant and benign lesions, and it has been shown to be useful for determining optimal treatment.

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

• The resistivity index

  The resistive index will be automatically calculated from at least 3 consecutive flow velocity waveforms

  10 minutes

Study Arms (1)

ovarian masses patients

women of different age groups diagnosed as having an ovarian mass or accidentally discovered ovarian mass in non-complaining female by ultrasonography or Patients known to have primary that may give metastasis to the ovaries.

Diagnostic Test: ultrasonography

Interventions

ultrasonography DIAGNOSTIC_TEST

A morphologic evaluation will be performed according to International Ovarian Tumor Analysis Group recommendations for the following parameters: Bilaterality , wall thickness, septations , papillary projections, solid areas, and echogenicity. The presence of ascites also will be recorded. Pattern recognition analysis will be used for ovarian masses highly suggestive of some diseases , then color Doppler will be activated to identify vascular color signals within the lesion.

ovarian masses patients

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will included 123 females Who referred to radiodiagnosis department at South Egypt Cancer Institute of different ages ,diagnosed as having ovarain mass

You may qualify if:

• All women of different age groups diagnosed as having an ovarian mass.
• Accidentally discovered ovarian mass in non-complaining female.
• Patients known to have primary that may give metastasis to the ovaries.

You may not qualify if:

• Patients receive neo adjuvant chemotherapy
• Recurrent ovarian masses

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine-Assuit Univeristy

Asyut, Egypt

Location

Related Publications (1)

• Zhang T, Li F, Liu J, Zhang S. Diagnostic performance of the Gynecology Imaging Reporting and Data System for malignant adnexal masses. Int J Gynaecol Obstet. 2017 Jun;137(3):325-331. doi: 10.1002/ijgo.12153. Epub 2017 Apr 12.

  PMID: 28295272 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Lamiaa M Refaat, Lecturer

  south egypt cancer institue,assuit univeristy

  STUDY DIRECTOR

• hagar HM Desoky, demonstrator

  south egypt cancer institue,assuit univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 5, 2017
• Study Start: July 5, 2018
• Primary Completion: February 26, 2019
• Study Completion: July 1, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)