Ovarian NeoplasmsNCT03175991
Gynacological Imaging Reporting and Data System in Ovarian Masses by Ultrasonography
An observational study of Ovarian Neoplasms, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- ultrasonography
- How many people
- 123 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2018to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Patients receive neo adjuvant chemotherapy
- Recurrent ovarian masses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gynacological Imaging Reporting and Data System in Classifying Ovarian Masses on the Basis of Ultrasonography
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.
Read the detailed description
Transvaginal Ultrasonography has been demonstrated to be the most sensitive and effective technique, being also non-invasive and in-expensive maneuver.Since in early reports, a standardized method for the description of the sonographic appearance of the ovarian masses was not used, the data of different studies are not easily compared.
In addition, there is no consensus on sonographic diagnostic criteria for ovarian cancer, despite many ultrasonography features being considered to be predictive of malignancy, such as presence of septations, internal nodularity, wall thickening, solid areas, free fluid or bilaterality.Usually the clinical management decision is based on data provided in the sonographic report. Many sonographers and sonologists use scoring systems to characterize ovarian masses, whereas others use the so called pattern recognition approach However, sometimes sonographic reports are misleading and confusing for the clinician. Although some groups have made considerable efforts in establishing terms and definitions for sonographic findings in ovarian masses .
In this study, we proposed a new data reporting system for sonographic findings in ovarian masses. This system is based on the concept developed for breast imaging, namely the Breast Imaging Reporting and Data System classification. Originally developed for mammographic findings, it has been successfully applied to breast sonography.
Like its breast sonographic counterpart, the gynacological imaging reporting and data system in ovarian masses by ultrasonography lexicon is intended to provide a unified language for sonographic reporting and for avoiding confusion in communication between the sonographer / sonologist and the clinician..
This system is based on a description of the ovarian mass using the pattern recognition approach and color Doppler blood flow location and the prior risk for malignancy in each group. On this basis, the proposed classification enables the sonologist or sonographer to give the clinician as much information as possible in a summarized way, as well as an estimated risk of malignancy, based only on the sonographic characteristics of the images.
Currently, there is enough evidence to indicate that when an experienced examiner performs the sonographic examination, such accuracy is achievable for most types of ovarian masses.
- Conditions
- Ovarian Neoplasms
- Being tested
- ultrasonography
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The resistivity index
The resistive index will be automatically calculated from at least 3 consecutive flow velocity waveforms
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start5 Jul 2018
- Primary completion26 Feb 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Desoky, Assiut University
- Investigators
- Lamiaa M Refaat, Lecturer, Study director, south egypt cancer institue,assuit univeristyhagar HM Desoky, demonstrator, Principal investigator, south egypt cancer institue,assuit univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175991
- Sponsor's protocol ID
- HAGAR098765
- Status last verified
- May 2020
- First submitted
- 29 May 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28295272
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynacological Imaging Reporting and Data System in Classifying Ovarian Masses on the Basis of Ultrasonography
- ClinicalTrials.gov ID
- NCT03175991
- Acronym / sponsor ID
- HAGAR098765
- Conditions
- Ovarian Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Transvaginal Ultrasonography has been demonstrated to be the most sensitive and effective technique, being also non-invasive and in-expensive maneuver.Since in early reports, a standardized method for the description of the sonographic appearance of the ovarian masses was not used, the data of different studies are not easily compared.
In addition, there is no consensus on sonographic diagnostic criteria for ovarian cancer, despite many ultrasonography features being considered to be predictive of malignancy, such as presence of septations, internal nodularity, wall thickening, solid areas, free fluid or bilaterality.Usually the clinical management decision is based on data provided in the sonographic report. Many sonographers and sonologists use scoring systems to characterize ovarian masses, whereas others use the so called pattern recognition approach However, sometimes sonographic reports are misleading and confusing for the clinician. Although some groups have made considerable efforts in establishing terms and definitions for sonographic findings in ovarian masses .
In this study, we proposed a new data reporting system for sonographic findings in ovarian masses. This system is based on the concept developed for breast imaging, namely the Breast Imaging Reporting and Data System classification. Originally developed for mammographic findings, it has been successfully applied to breast sonography.
Like its breast sonographic counterpart, the gynacological imaging reporting and data system in ovarian masses by ultrasonography lexicon is intended to provide a unified language for sonographic reporting and for avoiding confusion in communication between the sonographer / sonologist and the clinician..
This system is based on a description of the ovarian mass using the pattern recognition approach and color Doppler blood flow location and the prior risk for malignancy in each group. On this basis, the proposed classification enables the sonologist or sonographer to give the clinician as much information as possible in a summarized way, as well as an estimated risk of malignancy, based only on the sonographic characteristics of the images.
Currently, there is enough evidence to indicate that when an experienced examiner performs the sonographic examination, such accuracy is achievable for most types of ovarian masses.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ovarian masses patients | – | Diagnostic Test: ultrasonographywomen 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. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients receive neo adjuvant chemotherapy
- Recurrent ovarian masses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographyA 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. | Diagnostic test | ovarian masses patients |
Primary outcome
The resistivity index
Time frame: 10 minutes
The resistive index will be automatically calculated from at least 3 consecutive flow velocity waveforms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 28295272Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lamiaa M Refaat, Lecturer study director
south egypt cancer institue,assuit univeristy
hagar HM Desoky, demonstrator principal investigator
south egypt cancer institue,assuit univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The resistivity index (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.