AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Egypt1 site
  • Beni-suef university Hospital

    Banī Suwayf, 62511

Other trials in Egypt

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:

  1. Detailed history taking: Personal history, Age, Obstetric history, past history and family history.
  2. Physical examination: General examination, Pelvic examination and Abdominal examination.
  3. Investigations: Routine labs; CBC, liver and kidney functions, FBS and 2HPP. Other labs; cancer antigen 125 (CA 125) as a tumor marker.
  4. 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.

  1. 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.

  1. First posted7 May 2024
  2. Study start1 Jun 2021
  3. Primary completion4 Jan 2023
  4. Study completion30 Jan 2023

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in