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

Completed

• Conditions: Ovarian Tumor; Ovarian Cancer

• Registration Number: NCT02326064
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-24
• Study First Posted: 2014-12-25
• Study Start: 2015-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2022-09-16
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-30
• Last Update Submitted: 2023-08-30
• Results First Posted: 2024-03-15
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 221

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor Marker HE4	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	Baseline	CA125 \< 35U/mL. Abnormal score if CA125 \> 35U/mL.

Trial Locations

Locations (4)

Centre Hospitalier de Cholet; 🇫🇷 Cholet, France

CHU de Nantes; 🇫🇷 Nantes, France

CH de Saint Nazaire; 🇫🇷 Saint Nazaire, France

CHD Vendée; 🇫🇷 La Roche sur Yon, France