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
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Ovarian Tumor Ovarian Cancer |
| Intervention | Not Provided |
| Phase | N/A |
| Sponsor | Centre Hospitalier Departemental Vendee |
| Responsible Party | Centre Hospitalier Departemental Vendee |
| ClinicalTrials.gov Identifier | NCT02326064 |
| First Received | December 22, 2014 |
| Last Updated | January 8, 2015 |
| Last verified | January 2015 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 22, 2014 |
|---|---|
| Last Updated Date | January 8, 2015 |
| Start Date | March 2015 |
| Estimated Primary Completion Date | April 2017 |
| Current Primary Outcome Measures | tumor marker CA125 and HE4 [Time Frame: Baseline] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
|---|---|
| Official Title | 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) |
| 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 Provided |
| Study Type | Observational |
| Study Phase | N/A |
| Study Design | Observational Model: Cohort, Time Perspective: Prospective |
| Condition |
|
| Intervention | Not Provided |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 250 |
| Estimated Completion Date | April 2017 |
| Estimated Primary Completion Date | October 2016 |
| 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Lucie AUZANNEAU, ARC 02 51 44 63 80 lucie.auzanneau@chd-vendee.fr |
| Location Countries | France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02326064 |
|---|---|
| Other Study ID Numbers | CHD064-14 |
| Has Data Monitoring Committee | No |
| Information Provided By | Centre Hospitalier Departemental Vendee |
| Study Sponsor | Centre Hospitalier Departemental Vendee |
| Collaborators | Not Provided |
| Investigators | Study Director: Guillaume DUCARME, PH CHD Vendée |
| Verification Date | January 2015 |
Locations[ + expand ][ + ]
| Centre Hospitalier de Cholet | Cholet, France, 49300 Principal Investigator: Céline Renaudeau, PHNot yet recruiting |
|---|---|
| CHD Vendée | La Roche sur Yon, France, 85925 Principal Investigator: Guillaume DUCARME, PHNot yet recruiting |
| CHU de Nantes | Nantes, France, 44093 Principal Investigator: Edouard VAUCEL, PHNot yet recruiting |
| CH de Saint Nazaire | Saint Nazaire, France, 44606 Principal Investigator: Mélanie RANDET, PHNot yet recruiting |