Ovarian CancerNCT06403072
(GI-RADS) in Preoperative Evaluation of Adnexal Masses
An observational study of Ovarian Cancer, run by Beni-Suef University at 1 site in Egypt.
Trial summary
prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- The Gynecologic Imaging-Reporting and Data System (GI-RADS)
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Jan 2023
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with pelvic pain due to accidently discovered adnexal mass
Who may be able to join
- Females complaining of pelvic pain due to adnexal mass
Who cannot join
- Presence of Sure signs of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of the Gynecologic Imaging-Reporting and Data System (GI-RADS) in Preoperative Evaluation of Adnexal Masses
prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass
Read the detailed description
After institutional ethical committee approval () and informed consent from the patients, this prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass
All women were subjected to the following:
- Detailed history taking: Personal history, Age, Obstetric history, past history and family history.
- Physical examination: General examination, Pelvic examination and Abdominal examination.
- Investigations: Routine labs; CBC, liver and kidney functions, FBS and 2HPP. Other labs; cancer antigen 125 (CA 125) as a tumor marker.
- Trans vaginal ultrasound: TVUS Written informed consent for participation and publication was obtained from each patient after receiving information about the details of the study. Confidentiality of patient's records was assured and maintained throughout the study.
One hundred (100) patients' pelvises were examined by transvaginal ultrasound in lithotomy position using endo-vaginal transducer and/or transabdominal ultrasound in the supine position in transverse and longitudinal plane and evaluated by B-mode ultrasonography, color, and spectral Doppler. Two expert examiners with more than 10 years' experience in gynecological ultrasound, performed all examinations and data was stored between one and four representative images on the database.
After the examinations, a combination of morphological features, color and spectral Doppler features, and then the lesion was evaluated according to GI-RADS classification, and the suggested management protocol based on the risk of malignancy.
Finally, the referral to surgery and decision-making were consulted in accordance with a multidisciplinary team meeting (MDT). A definitive histopathological diagnosis was obtained as a gold standard test for all patients with GI-RADS 4 and 5 and some cases of GI-RADS 3 patients after laparoscopic or surgical removal of the masses.
A morphologic evaluation was performed according to the International Ovarian Tumor Analysis Group (IOTA) recommendations for the following parameters: wall thickness, septation, papillary projections, presence and echogenicity of solid areas, presence of mixed component, cystic component, and presence of ascites and intra-abdominal metastases (peritoneal deposits, liver metastasis, and malignant abdominal lymphadenopathy) was also recorded. Pattern recognition analysis was also used for ovarian masses.
Statistical analysis:
The collected data was coded, tabulated, and statistically analyzed using IBM SPSS statistics (Statistical Package for Social Sciences) software version 22.0, IBM Corp., Chicago, USA, 2013 and Microsoft Office Excel 2007.
- Conditions
- Ovarian Cancer
- Being tested
- The Gynecologic Imaging-Reporting and Data System (GI-RADS)
- Keywords
- Gynecologic Imaging-Reporting and Data System, Adnexal Masses, Ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Gynecologic Imaging-Reporting and Data System (GI-RADS)Diagnostic test
The Gynecologic Imaging-Reporting and Data System (GI-RADS) using ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gynecologic Imaging-Reporting and Data System (GI-RADS)
is a reporting system that was created for reporting the findings in adnexal masses based on transvaginal ultrasonography.
Measured: 1 month from admission to ultrasound investigation and operation and finally histopathology report
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jun 2021
- Primary completion4 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
- Investigators
- Sara S Sara Salem, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403072
- Sponsor's protocol ID
- GI-RADS
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of the Gynecologic Imaging-Reporting and Data System (GI-RADS) in Preoperative Evaluation of Adnexal Masses
- ClinicalTrials.gov ID
- NCT06403072
- Acronym / sponsor ID
- GI-RADS
- Conditions
- Ovarian Cancer
- Keywords
- Gynecologic Imaging-Reporting and Data System, Adnexal Masses, Ovarian cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 7 May 2024 (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.
prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass
Detailed description
After institutional ethical committee approval () and informed consent from the patients, this prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass
All women were subjected to the following:
- Detailed history taking: Personal history, Age, Obstetric history, past history and family history.
- Physical examination: General examination, Pelvic examination and Abdominal examination.
- Investigations: Routine labs; CBC, liver and kidney functions, FBS and 2HPP. Other labs; cancer antigen 125 (CA 125) as a tumor marker.
- Trans vaginal ultrasound: TVUS Written informed consent for participation and publication was obtained from each patient after receiving information about the details of the study. Confidentiality of patient's records was assured and maintained throughout the study.
One hundred (100) patients' pelvises were examined by transvaginal ultrasound in lithotomy position using endo-vaginal transducer and/or transabdominal ultrasound in the supine position in transverse and longitudinal plane and evaluated by B-mode ultrasonography, color, and spectral Doppler. Two expert examiners with more than 10 years' experience in gynecological ultrasound, performed all examinations and data was stored between one and four representative images on the database.
After the examinations, a combination of morphological features, color and spectral Doppler features, and then the lesion was evaluated according to GI-RADS classification, and the suggested management protocol based on the risk of malignancy.
Finally, the referral to surgery and decision-making were consulted in accordance with a multidisciplinary team meeting (MDT). A definitive histopathological diagnosis was obtained as a gold standard test for all patients with GI-RADS 4 and 5 and some cases of GI-RADS 3 patients after laparoscopic or surgical removal of the masses.
A morphologic evaluation was performed according to the International Ovarian Tumor Analysis Group (IOTA) recommendations for the following parameters: wall thickness, septation, papillary projections, presence and echogenicity of solid areas, presence of mixed component, cystic component, and presence of ascites and intra-abdominal metastases (peritoneal deposits, liver metastasis, and malignant abdominal lymphadenopathy) was also recorded. Pattern recognition analysis was also used for ovarian masses.
Statistical analysis:
The collected data was coded, tabulated, and statistically analyzed using IBM SPSS statistics (Statistical Package for Social Sciences) software version 22.0, IBM Corp., Chicago, USA, 2013 and Microsoft Office Excel 2007.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with pelvic pain due to accidently discovered adnexal mass
Key inclusion criteria (1 listed)
- Females complaining of pelvic pain due to adnexal mass
Key exclusion criteria (1 listed)
- Presence of Sure signs of malignancy
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 |
|---|---|---|
| The Gynecologic Imaging-Reporting and Data System (GI-RADS)The Gynecologic Imaging-Reporting and Data System (GI-RADS) using ultrasound | Diagnostic test | – |
Primary outcome
The Gynecologic Imaging-Reporting and Data System (GI-RADS)
Time frame: 1 month from admission to ultrasound investigation and operation and finally histopathology report
is a reporting system that was created for reporting the findings in adnexal masses based on transvaginal ultrasonography.
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 7 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Sara S Sara Salem principal investigator
Beni-Suef University
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 Cancer, run by Beni-Suef 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 1 inclusion and 1 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 7 May 2024. 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 Gynecologic Imaging-Reporting and Data System (GI-RADS) (time frame: 1 month from admission to ultrasound investigation and operation and finally histopathology report). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.