Clinical trial · Observational
Screening for Ovarian Malignancy
Assessment of Different Neoplasias in the Adenxa Model Versus Risk of Malignancy Index as a Tool for Predicting Ovarian Malignancy in Postmenopausal Ovarian Cysts
- 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)
Ovarian cancer is the second most common gynecologic malignancy. In 2008, it was the seventh leading cause of cancer deaths in women worldwide. Estimating the risk of malignancy is essential in the management of adnexal masses and several mathematical models and scoring systems have been developed to be used for discrimination between benign and malignant adnexal masses. Knowledge of the specific type of adnexal pathology before surgery is likely to improve patient triage with high accuracy, and it also makes it possible to optimize treatment. The correct identification of stage I cancer is particularly important
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 |
|---|---|---|---|
| Early Detection of Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assesment of Different NEoplasias in the adenexa model | Diagnostic Test | — | UNRESOLVED |
| Histopathologic examination | Diagnostic Test | — | UNRESOLVED |
| Risk of malignancy index | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity, specificity, positive predictive, and negative predictive value of Assessment of Different NEoplasias in the adneXa model for differentiating between benign and malignant ovarian tumors
- timeFrame
- within 120 days from the scheduled surgery date
- description
- The diagnostic performance of the ADNEX model for differentiating between benign and malignant ovarian tumors was assessed at a threshold of 10%. The diagnostic performance was expressed as Area Under Receiver Operating Characteristic Curve (AUC)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * All the included patients were postmenopausal; postmenopausal status was defined as having ≥ 1 year of amenorrhea without using any contraceptive method in women ≥ 45 years while for women \< 45 years, two consecutive FSH samples one 1month apart with levels ≥ 30 IU/L were required to confirm menopause Exclusion Criteria: * Accidental discovery of ovarian mass during surgery for other reasons * Patients with known ovarian cancer who were scheduled for interval debulking after neoadjuvant chemotherapy
References
Publications (16)
- BACKGROUNDNash Z, Menon U. Ovarian cancer screening: Current status and future directions. Best Pract Res Clin Obstet Gynaecol. 2020 May;65:32-45. doi: 10.1016/j.bpobgyn.2020.02.010. Epub 2020 Mar 3. PMID 32273169
- BACKGROUNDNohuz E, De Simone L, Chene G. Reliability of IOTA score and ADNEX model in the screening of ovarian malignancy in postmenopausal women. J Gynecol Obstet Hum Reprod. 2019 Feb;48(2):103-107. doi: 10.1016/j.jogoh.2018.04.012. Epub 2018 Apr 28. PMID 29709594
- BACKGROUNDAli MN, Habib D, Hassanien AI, Abbas AM. Comparison of the four malignancy risk indices in the discrimination of malignant ovarian masses: A cross-sectional study. J Gynecol Obstet Hum Reprod. 2021 May;50(5):101986. doi: 10.1016/j.jogoh.2020.101986. Epub 2020 Nov 13. PMID 33197624
- BACKGROUNDBarrenada L, Ledger A, Dhiman P, Collins G, Wynants L, Verbakel JY, Timmerman D, Valentin L, Van Calster B. ADNEX risk prediction model for diagnosis of ovarian cancer: systematic review and meta-analysis of external validation studies. BMJ Med. 2024 Feb 17;3(1):e000817. doi: 10.1136/bmjmed-2023-000817. eCollection 2024. PMID 38375077
- BACKGROUNDWang R, Yang Z. Evaluating the risk of malignancy in adnexal masses: validation of O-RADS and comparison with ADNEX model, SA, and RMI. Ginekol Pol. 2023;94(10):799-806. doi: 10.5603/GP.a2023.0019. Epub 2023 Mar 17. PMID 36929789
- BACKGROUNDMunro MG, Critchley HOD, Fraser IS; FIGO Menstrual Disorders Committee. The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions. Int J Gynaecol Obstet. 2018 Dec;143(3):393-408. doi: 10.1002/ijgo.12666. Epub 2018 Oct 10. PMID 30198563
- BACKGROUNDAli AT, Al-Ani O, Al-Ani F. Epidemiology and risk factors for ovarian cancer. Prz Menopauzalny. 2023 Jun;22(2):93-104. doi: 10.5114/pm.2023.128661. Epub 2023 Jun 14.