Clinical trial · Observational
IOTA Ultrasound Criteria and Serum CA 125 for Ovarian Malignancy Detection
Identification of Ovarian Malignancy With Ultrasonography Based Criteria (IOTA) and Serum CA 125
NCT06977334CI-TRIAL-00089894IOTA-CA125completedClinicalTrials.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)
This cross-sectional analytic study assessed the diagnostic accuracy of IOTA Simple Rules versus serum CA 125 in women with adnexal masses undergoing surgery. Eighty-two percent of tumors were classifiable by IOTA criteria; CA 125 cut-offs of 35, 70, and 105 U/mL were evaluated against histopathology gold standard.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Sensitivity of IOTA Simple Rules
- timeFrame
- At surgery/histopathology
- description
- Proportion of histologically malignant masses correctly identified by IOTA criteria.
- measure
- Specificity of IOTA Simple Rules
- timeFrame
- At surgery/histopathology
- description
- Proportion of histologically malignant masses correctly identified by IOTA criteria.
- measure
- Sensitivity of Serum CA 125 (cut-off 35 U/mL)
- timeFrame
- Preoperative blood draw
- description
- Proportion of malignant tumors with CA 125 \>35 U/mL.
- measure
- Specificity of Serum CA 125 (cut-off 35 U/mL)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All age groups and parity with ovarian mass admitted for scheduled surgery. Exclusion Criteria: * Proven cases of ovarian malignancy * Ovarian mass in pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.