Clinical trial · Interventional
IOTA Versus Pattern Recognition Method in Diagnosis of Ovarian Masses
The Diagnostic Value Of International Ovarian Tumour Analysis (IOTA) Simple Rules Versus the Pattern Recognition Method In Differentiating Between Malignant And Benign Adnexal Masses
NCT02800031CI-TRIAL-00036417completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare between the efficacy of IOTA simple rules and pattern recognition method in the differentiating between benign and malignant adnexal masses
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transvaginal ultrasonography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants
- description
- * 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.
- interventionNames
- Device: Transvaginal ultrasonography
Primary outcomes (1)
- measure
- comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses
- timeFrame
- 12 month
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Complicated ovarian masses. * Unfit for surgery.
References
Publications (1)
- DERIVEDDakhly 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. PMID 31520402