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ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Assesment of Different NEoplasias in the adenexa model +2 moreother
Likely dose
Not stated in record
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Search/NCT06348784
NCT06348784N/ACompleted

Assessment of Different Neoplasias in the Adenxa Model Versus Risk of Malignancy Index as a Tool for Predicting Ovarian Malignancy in Postmenopausal Ovarian Cysts

Ain Shams Maternity Hospital·observational·Posted Apr 5, 2024·Updated Apr 5, 2024

In Brief

An observational study evaluating Assesment of Different NEoplasias in the adenexa model, Risk of malignancy index, and 1 other intervention for Early Detection of Ovarian Cancer. Completed, enrolled 50 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 5, 2024
Enrollment StartJan 1, 2022
Primary CompletionJan 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 2.2 years ago

Interventions

Assesment of Different NEoplasias in the adenexa modelother

The ADNEX model includes nine parameters; Age, CA-125 level, Oncology center (yes/no), and 6 ultrasound features which are maximal diameter of the lesion, maximal diameter of the largest solid part, more than 10 locules (yes/no), number of papillary projections (0/1/2/3/more than 3), acoustic shadow, and ascites

Risk of malignancy indexother

The RMI was measured as follows; Menopausal status (score is 3 as all patients were postmenopausal X Ultrasound score is based on assessment of 5 features and with the presence of one feature, the score is 1 while if more than one feature is present, the score is 3; the five ultrasound features are the presence of solid components, multilocularity, bilaterality, ascites, and metastases X CA - 125 level

Histopathologic examinationother

Histopathologic examination of all excised specimens was done as this is the gold standard test for detecting ovarian malignancy