GynecologyNCT02800031
IOTA Versus Pattern Recognition Method in Diagnosis of Ovarian Masses
A study testing Transvaginal ultrasonography in people with Gynecology, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
To compare between the efficacy of IOTA simple rules and pattern recognition method in the differentiating between benign and malignant adnexal masses Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Gynecology
- What is being tested?
- Transvaginal ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to Nov 2018
- Phase
- Interventional
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ovarian mass more than 5 cm in size (confirmed by transvaginal or transabdominal ultrasonography in gynecology clinic)
- The patient is candidate for abdominal exploration for ovarian Cystectomy or oophorectomy.
Who cannot join
- Complicated ovarian masses.
- Unfit for surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Diagnostic Value Of International Ovarian Tumour Analysis (IOTA) Simple Rules Versus the Pattern Recognition Method In Differentiating Between Malignant And Benign Adnexal Masses
To compare between the efficacy of IOTA simple rules and pattern recognition method in the differentiating between benign and malignant adnexal masses
- Conditions
- Gynecology
- Being tested
- Transvaginal ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasonographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | * Level-II Transvaginal ultrasonography will be done by the principle investigator (who is unaware about the recognition pattern method) to confirm the presence of the ovarian mass and measure its size and to apply the IOTA simple rules on it (complimentary transabdominal ultrasound might be done for huge pelvi-abdominal masses originating from the ovary).
* Level-III ultrasound will be done by expert ultrasound operator (who is blinded to the results of IOTA simple rules assessment of the examined mass) to classify the mass (either benign or malignant) using the pattern recognition method.
* Plan of management for each patient will be based solely on the findings of pattern recognition and the patient's wishes.
* Exploratory laparotomy for excision of the ovarian mass either by ovarian Cystectomy or oophorectomy.
* All specimens will be examined histopathologically. Receives: Device: Transvaginal ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2018
- Study completionNov 2018
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 GynecologyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
- Investigators
- Dina MR Dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800031
- Sponsor's protocol ID
- HJ200516
- Status last verified
- Jan 2019
- First submitted
- 26 Apr 2016
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Dakhly DMR, Gaafar HM, Sediek MM, Ibrahim MF, Momtaz M. Diagnostic value of the International Ovarian Tumor Analysis (IOTA) simple rules versus pattern recognition to differentiate between malignant and benign ovarian masses. Int J Gynaecol Obstet. 2019 Dec;147(3):344-349. doi: 10.1002/ijgo.12970. Epub 2019 Sep 26.
PubMed 31520402
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value Of International Ovarian Tumour Analysis (IOTA) Simple Rules Versus the Pattern Recognition Method In Differentiating Between Malignant And Benign Adnexal Masses
- ClinicalTrials.gov ID
- NCT02800031
- Acronym / sponsor ID
- HJ200516
- Conditions
- Gynecology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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.
To compare between the efficacy of IOTA simple rules and pattern recognition method in the differentiating between benign and malignant adnexal masses
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Device: Transvaginal ultrasonography* Level-II Transvaginal ultrasonography will be done by the principle investigator (who is unaware about the recognition pattern method) to confirm the presence of the ovarian mass and measure its size and to apply the IOTA simple rules on it (complimentary transabdominal ultrasound might be done for huge pelvi-abdominal masses originating from the ovary). * Level-III ultrasound will be done by expert ultrasound operator (who is blinded to the results of IOTA simple rules assessment of the examined mass) to classify the mass (either benign or malignant) using the pattern recognition method. * Plan of management for each patient will be based solely on the findings of pattern recognition and the patient's wishes. * Exploratory laparotomy for excision of the ovarian mass either by ovarian Cystectomy or oophorectomy. * All specimens will be examined histopathologically. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ovarian mass more than 5 cm in size (confirmed by transvaginal or transabdominal ultrasonography in gynecology clinic)
- The patient is candidate for abdominal exploration for ovarian Cystectomy or oophorectomy.
Key exclusion criteria (2 listed)
- Complicated ovarian masses.
- Unfit for surgery.
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 |
|---|---|---|
| Transvaginal ultrasonography | Device | Participants |
Primary outcome
comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses
Time frame: 12 month
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 8 Jan 2019.
- Derived from this study: PubMed 31520402Dakhly DMR, Gaafar HM, Sediek MM, Ibrahim MF, Momtaz M. Diagnostic value of the International Ovarian Tumor Analysis (IOTA) simple rules versus pattern recognition to differentiate between malignant and benign ovarian masses. Int J Gynaecol Obstet. 2019 Dec;147(3):344-349. doi: 10.1002/ijgo.12970. Epub 2019 Sep 26.
- 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.
Dina MR Dakhly, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal ultrasonography in people with Gynecology, run by Woman's Health University Hospital, Egypt 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 2 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 8 Jan 2019. 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?
comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses (time frame: 12 month). 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 NCT02800031, 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 8 Jan 2019.