N/A
N=221
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
Ovarian Tumor · Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02326064 ↗Enrolled (actual)
221
Serious AEs
—
Results posted
Mar 2024
Primary outcome: Primary: Tumor Marker CA125 — 189; 4 U/mL — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Centre Hospitalier Departemental Vendee
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Marker CA125 |
189; 4 | <0.001 sig |
| PRIMARY Tumor Marker HE4 |
191; 6 | <0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02326064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.