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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

NCT02326064 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 221

Last updated 2025-12-02

Study results available
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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

Sponsors & Collaborators

  • Centre Hospitalier Departemental Vendee

    lead OTHER

Principal Investigators

  • Guillaume DUCARME, PH · CHD Vendée

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02326064 on ClinicalTrials.gov