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HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental arm | Other | Serum samples are collected:
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the predictive and prognostic value of HE4 marker | Serum concentration of HE4 (pMol) will be analysed at each visit | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the evolution of HE4 and CA-125 serum concentration | Serum concentration of HE4 and CA-125 (pMol) will be analysed and compared at the time of diagnosis, at each neoadjuvant chemotherapy cycle, before the surgery, and at each chemotherapy cycle | 24 months |
| Evaluate the progression-free survival at 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Céline Gavoille, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BENGRINE-LEVEVRE Leïla | Dijon | Centre Georges François Leclerc | 21 079 | France | ||
| DEMARCHI Martin |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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HE4 and CA125 will be compared with the rate of progression-free survival |
| 24 months |
| Evaluate the quality of surgery | HE4 and CA125 will be compared with completeness of cancer resection score (CCR score). | 24 months |
| Strasbourg |
| Centre Paul Strauss |
| 67065 |
| France |
| LONGO Raphaelle | Metz | CHU Metz Thionville | 57085 | France |
| KURTZ Jean-Emmanuel | Strasbourg | Hôpital Civil | 67 091 | France |
| KALBACHER Elsa | Besançon | Hôpital Jean Minjoz | 25 030 | France |
| GAVOILLE Céline | Vandœuvre-lès-Nancy | Institut de Cancérologie de Lorraine | 54 519 | France |
| SAVOYE Aude-Marie | Reims | Institut Jean Godinot | 51 056 | France |
| 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 |