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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ovarian Tumor
- Sponsor
- Centre Hospitalier Departemental Vendee
- Enrollment
- 221
- Locations
- 4
- Primary Endpoint
- Tumor Marker HE4
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients to undergo surgery for an ovarian cyst
- •presumed benign ovarian tumor (according to the rules of the IOTA(International Ovarian Tumor Analysis Group) group)
- •agreement to participate in the study
Exclusion Criteria
- •pregnant patient
- •minor patient
- •Patient under guardianship, trusteeship, or deprived of liberty
- •Patient with ascites or metastases or malignant ovarian mass presumed under the rules of IOTA group.
- •Patient with an adnexal torsion is suspected
- •Patient unable to understand the proposed study
Outcomes
Primary Outcomes
Tumor Marker HE4
Time Frame: Baseline
HE4 \< 70 pmol/L for premenopausal women or \< 140 pmol/L for postmenopausal women Abnormal score if HE4 \> 70 pmol/L for premenopausal women or \> 140 pmol/L for postmenopausal women
Tumor Marker CA125
Time Frame: Baseline
CA125 \< 35U/mL. Abnormal score if CA125 \> 35U/mL.