Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348784
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2024-03-25
Brief Title:
Screening for Ovarian Malignancy
Sponsor:
Ain Shams Maternity Hospital
Organization:
Ain Shams Maternity Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 117 - 121 per 100000 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 isnt 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None