NCT02326064

Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI and Tumor Markers Such as CA125 and HE4

Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI (Risk of Malignancy Index) and Tumor Markers Such as CA125 (Cancer Antigen 125) and HE4 (Human Epididymal Protein 4)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 221 (actual)
• Sponsor: Centre Hospitalier Departemental Vendee · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor. To date, there is only one biological tumor marker routinely performed before an ovarian cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and show a sensitivity and specificity unsatisfactory in view of the severity of the disease. The principal investigator therefore propose to evaluate a new tumor marker, as well as its use in algorithms to help differentiate benign from malignant tumors, and allow earlier diagnosis in cases of ovarian cancer.

Conditions

• Ovarian Tumor
• Ovarian Cancer

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-12-25
• Last updated: 2025-12-02
• Results posted: 2024-03-15

Locations

4 sites across 1 country: France