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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Tumor Marker CA125 | CA125 < 35U/mL. Abnormal score if CA125 > 35U/mL. | Baseline |
| Tumor Marker HE4 | HE4 < 70 pmol/L for premenopausal women or < 140 pmol/L for postmenopausal women Abnormal score if HE4 > 70 pmol/L for premenopausal women or > 140 pmol/L for postmenopausal women | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patient hospitalized for surgery for presumed benign ovarian tumor
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume DUCARME, PH | CHD Vendée | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Cholet | Cholet | 49300 | France | |||
| CHD Vendée |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30917847 | Background | 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. | |
| 31699959 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Women with benign ovarian tumour | |
| FG001 | Women with borderline/ malign ovarian tumour |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| La Roche-sur-Yon |
| 85925 |
| France |
| CHU de Nantes | Nantes | 44093 | France |
| CH de Saint Nazaire | Saint-Nazaire | 44606 | France |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Women With Benign Ovarian Tumour | |
| BG001 | Women With Borderline/ Malign Ovarian Tumour | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Tumor Marker CA125 | CA125 < 35U/mL. Abnormal score if CA125 > 35U/mL. | Posted | Mean | Standard Deviation | U/mL | Baseline |
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| Primary | Tumor Marker HE4 | HE4 < 70 pmol/L for premenopausal women or < 140 pmol/L for postmenopausal women Abnormal score if HE4 > 70 pmol/L for premenopausal women or > 140 pmol/L for postmenopausal women | Posted | Mean | Standard Deviation | pmol/L | Baseline |
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Not applicable - not required by French law Serious adverse events and other [non-serious] events were not collected and therefore not evaluated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women with benign ovarian tumour | 0 | 0 | 0 | 0 | |||
| EG001 | Women with borderline/ malign ovarian tumour | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Guillaume DUCARME | Centre Hospitalier Départemental Vendée | 0251446161 | guillaume.ducarme@ght85.fr |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| Male |
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