Screening for Ovarian Malignancy

NCT06348784CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Ain Shams Maternity Hospital

Enrollment

50

Start Date

2022-01-01

Completion Date

2023-01-01

Study Type

OBSERVATIONAL

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

Interventions

Assesment of Different NEoplasias in the adenexa modelRisk of malignancy indexHistopathologic examination

Conditions

Early Detection of Ovarian Cancer

Eligibility

Age Range

40 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

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)

Time frame: within 120 days from the scheduled surgery date

Locations

AinShams university maternity hospital, Cairo, Egypt

Linked Papers

2023-01-24

Ovulation induction drug and ovarian cancer: an updated systematic review and meta-analysis

Abstract Objective To explore the association between ovulation induction drugs and ovarian cancer. Design Systematic review and meta-analysis. Setting Not applicable. Patient(s) Women without ovarian cancer who ever or never underwent ovarian induction. Intervention(s) An extensive electronic search of the following databases was performed: PubMed, EMBASE, MEDLINE, Google Scholar, Cochrane Library and CNKI, from inception until January 2022. A total of 34 studies fulfilled our inclusion criteria and were included in the final meta-analysis. The odds ratio (OR) and random-effects model were used to estimate the pooled effects. The Newcastle-Ottawa Scale was used to assess the quality of included studies. Funnel plots and Egger tests were used to assess publication bias. Main outcomes New diagnosed borderline ovarian tumor (BOT) and invasive ovarian cancer (IOC) between ovulation induction (OI) group and control (CT) group considering fertility outcome, OI cycles and specific OI drugs. Results Primarily, there was no significant difference in the incidence of IOC and BOT between the OI and CT groups. Secondly, OI treatment did not increase the risk of IOC and BOT in the multiparous women, nor did it increase the risk of IOC in the nulliparous women. However, the risk of BOT appeared to be higher in nulliparous women treated with OI treatment. Thirdly, among women exposed to OI, the risk of IOC and BOT was higher in nulliparous women than in multiparous women. Fourthly, the risk of IOC did not increase with increasing OI cycles. Lastly, exposure to specific OI drugs also did not contribute to the risk of IOC and BOT. Conclusion Overall, OI treatment did not increase the risk of IOC and BOT in most women, regardless of OI drug type and OI cycle. However, nulliparous women treated with OI showed a higher risk of ovarian cancer, necessitating their rigorous monitoring and ongoing follow-up.

2022-08-01

The Optimal Cut-Off Point of the Andex Model for the Prediction of the Ovarian Cancer Risk

Objective: This study aimed to assess the effectiveness and determine the optimal cut-off point of the ADNEX model in women presenting with a pelvic or adnexal tumor. Method: All women presented with adnexal mass and were scheduled for operation at Hue University of Medicine and Pharmacy Hospital and Hue Central Hospital, Vietnam during June 2019 – May 2021 were included and categorized according to their histopathologic reports into ovarian cancer groups and benign ovarian tumor groups. Multivariable logistic regression was used to explore for potential predictors. The ADNEX model with and without CA125 was used to assess the risk of ovarian cancer preoperative. The goldden standard to evaluate the accuracy of ultrasonography using the ADNEX model was the pathological report. In addition, the accuracy as well as optimum cut-off point of the ADNEX model was estimated with and without CA125. Results: A total of 461 participants were included in analysis and predictive model development, 65 patients in ovarian cancer group and 361 in benign tumor group. The ADNEX model combined with CA125 proved to be a useful predictor with an area under ROC of 0.961 (0.940 – 0.977) with Youden’s index of 0.8395, p < 0.001. The ADNEX model without CA125 also had high predictive value between benign and malignant tumors, with an area under ROC of 0.956 (0.933 – 0.973) with Youden’s index of 0.8551, p < 0.001. Cut-off of the ADNEX with CA125 was 13.5 and without CA125 was 13.1 for sensitivities were 90.8 (81.0 – 96.5) and 93.9 (85.0 – 97.5), specificities 93.2 (90.2 – 95.5) and 91.67 (88.5 – 94.2). The difference in the predictive value of malignancy-risk between the ADNEX model with CA125, without CA125 was not statistically significant, p=0.4883. Conclusion: The ADNEX model, with or without the combining marker CA 125, provides a valuable predictive value for ovarian tumor malignancy preoperative.

2020-11-13

RETRACTED: Comparison of the four malignancy risk indices in the discrimination of malignant ovarian masses: A cross-sectional study

To evaluate the accuracy of the four malignancy risk indices to distinguish benign from malignant ovarian masses MATERIALS AND METHODS: This was an observational cross-sectional study conducted on 155 patients between January 2016 and January 2019. Women with ovarian masses planned for surgical management were recruited from the outpatient Gynecology clinic of the hospital. The risk of malignancy index (RMI 1-4) was calculated for all women with ovarian masses. Biopsies obtained from the ovarian masses after the surgical intervention was sent to the pathology lab for histopathological examination. The histopathologic diagnosis of the ovarian masses was considered the gold standard for diagnosis. The participants' mean age in the group of patients with benign masses was 33.50 ± 14.53 years versus 45.09 ± 13.67 years in the malignant group. The two most prominent features in the malignant group were solid areas in 85.3 % of malignant masses and about 91.2 % of malignant masses showing size <7 cm in their largest diameter. The RMI's most sensitive individual parameter was the CA-125 level, while the lowest sensitivity was for the menopausal status. RMI 2 had the highest sensitivity of 76.47 %, while RMI 1 and 3 had the highest specificity, 92.56 %. RMI 2 had the highest AUC, 0.83. RMI 2 is a simple and reliable tool and had the best performance among all RMIs in benign discrimination from malignant ovarian masses with high sensitivity and accuracy.

Linked Investigators

Minh Tam Le

Dr. Le Minh Tam earned his medical degree from Hue University of Medicine and Pharmacy (Hue UMP), Vietnam, and has been a faculty member of the Department of Obstetrics and Gynecology since 2001. In 2004, he completed his master’s degree in obstetrics and gynecology at the same institution. From 2006 to 2009, he was awarded a long-term DAAD fellowship (German Academic Exchange Service) to pursue a Ph.D. in Obstetrics and Gynecology at the University of Freiburg, Germany. Currently, Dr. Tam serves as a senior lecturer in the Department of Obstetrics and Gynecology at Hue UMP, vice chairman of the department, and director of the Center for Reproductive Endocrinology and Infertility (HueCREI). He is also an executive committee member of the Vietnam Society of Gynecology and Obstetrics (VAGO), general secretary of the Vietnamese Journal of Obstetrics and Gynecology (VJOG), and vice president of the Vietnam Society for Sexual Medicine (VSSM). Dr. Tam has received extensive training in reproductive medicine at internationally recognized institutions, including Shady Grove Fertility, Maryland, USA (2014); University Hospital Tartu, Estonia (2013); PREG Centers, Greenville, South Carolina, and Memphis, Tennessee, USA (2012); University of Tsukuba, Japan (2011); Freiburg Women’s Hospital, Germany (2006–2009); University Hospital of Guangzhou, China (2006); and a one-year IVF training program (2003) He has authored approximately 120 scientific articles in Vietnamese medical journals (with over 75% as first or corresponding authors), 68 international publications indexed in ISI/Scopus, and has presented at more than 20 professional conferences. His current H-index is 19. Key Research Interests: 1. Male infertility and sperm quality, which includes sperm DNA fragmentation, the effects of reactive oxygen species (ROS), metabolic syndrome in men, and cryopreservation techniques. 2. Disorders of gynecologic endocrinology, especially PCOS; controlled ovarian hyperstimulation in female infertility. 3. Assisted reproductive technologies and embryo culture. 4. Gynecologic infections, particularly human papillomavirus (HPV) and cervical intraepithelial lesions.