Clinical trial NCT06348784: Screening for Ovarian Malignancy
Official title: Assessment of Different Neoplasias in the Adenxa Model Versus Risk of Malignancy Index as a Tool for Predicting Ovarian Malignancy in Postmenopausal Ovarian Cysts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Detection of Ovarian Cancer
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participants were 50 postmenopausal patients who presented to the general gynecology or gynecological oncology outpatient clinic with adnexal mass.

Brief 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

Detailed description: Ovarian cancer (OC) is the third most common gynecological malignancy worldwide and carries the highest mortality. OC has an incidence of 11.7 - 12.1 per 100,000 in the USA and Europe, with slightly lower rates of disease in Asia and the Middle East. Most patients (60%) are diagnosed with advanced disease which is associated with significant mortality. The most important factor for survival is the stage at diagnosis and nowadays there isn't a proven effective screening strategy. It is necessary to identify the best tool to detect early-stage disease. To reduce the diagnostic dilemma between benign and malignant ovarian masses, a formula-based scoring system known as the risk of malignancy index (RMI) was introduced in 1990, which was termed RMI 1. RMI is a combined parameter that is simple, specific, and highly sensitive for the evaluation of adnexal masses. It is a product of ultrasound findings (U), the menopausal status (M), and serum CA-125 levels (RMI = U X M XCA-125). The original RMI (RMI-1) was modified in 1996 as (RMI 2) and again in 1999 known as (RMI 3), and the last modification was in 2009 by adding the tumor size (S) to the equation and calling it RMI 4. A systematic review of diagnostic studies concluded that the RMI I was the most effective for women with suspected ovarian malignancy.

Malignant tumors benefit from management in specialized oncology centers, but borderline malignancies, stage I primary invasive tumors, and advanced primary invasive tumors might require different surgical approaches. To optimize patient triage without operating on all masses, diagnostic models can be used to estimate the likelihood of malignancy and hence to plan treatment for patients. The International Ovarian Tumor Analysis Group (IOTA) has developed a multi-tumor prediction model, Assessment of Different NEoplasias in the adneXa (ADNEX) model, which is used to describe in detail the characteristics of adnexal masses. ADNEX model can not only distinguish the probability of benign and malignant AMs, but also distinguish between borderline ovarian tumors, stage I ovarian cancer, stage II-IV ovarian cancer, and secondary metastatic ovarian cancers, which includes three clinical features and six ultrasound features

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
Study officials:
affiliation: Ain Shams University
name: Amr H El-Shalakany, M.D.
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Kareem M Labib, M.D.
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Hassan Morsi, PhD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Mortada Elsayed, M.D.
role: STUDY_CHAIR
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