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
NCT ID: NCT02326064
Last Updated: 2025-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
221 participants
OBSERVATIONAL
2015-05-31
2016-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Departemental Vendee
OTHER
Responsible Party
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Principal Investigators
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Guillaume DUCARME, PH
Role: STUDY_DIRECTOR
CHD Vendée
Locations
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Centre Hospitalier de Cholet
Cholet, , France
CHD Vendée
La Roche-sur-Yon, , France
CHU de Nantes
Nantes, , France
CH de Saint Nazaire
Saint-Nazaire, , France
Countries
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References
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Dochez V, Caillon H, Vaucel E, Dimet J, Winer N, Ducarme G. Biomarkers and algorithms for diagnosis of ovarian cancer: CA125, HE4, RMI and ROMA, a review. J Ovarian Res. 2019 Mar 27;12(1):28. doi: 10.1186/s13048-019-0503-7.
Dochez V, Randet M, Renaudeau C, Dimet J, Le Thuaut A, Winer N, Thubert T, Vaucel E, Caillon H, Ducarme G. Efficacy of HE4, CA125, Risk of Malignancy Index and Risk of Ovarian Malignancy Index to Detect Ovarian Cancer in Women with Presumed Benign Ovarian Tumours: A Prospective, Multicentre Trial. J Clin Med. 2019 Oct 25;8(11):1784. doi: 10.3390/jcm8111784.
Other Identifiers
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CHD064-14
Identifier Type: -
Identifier Source: org_study_id
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