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 (TORCH)

Centre Hospitalier Departemental Vendee

Status: Completed

Conditions: Ovarian Tumor; Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02326064

CHD064-14

Details and patient eligibility

About

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.

Enrollment: 221 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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