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| Name | Class |
|---|---|
| Monitoring Force Group | INDUSTRY |
| iGenSeq | UNKNOWN |
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OVAmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in 8 obstetrics and gynecology departments in France; in order to describe the evolution of salivary miRNA expression between the pre-operative and post-therapy visits according to the type of mass. In time, the clinical application will be to significantly reduce the time to diagnosis and improve the care pathway for ovarian adnexal mass.
The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI) and requiring surgical management in routine care.
The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.
In this study, the management and follow-up of patients :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyst Benign | 400 patients |
| |
| Ovarian Cancer | 200 patients |
| |
| Borderline Ovarian Cancer | 60 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salivary samples | Other | For patients with a benign ovarian cyst, 1 saliva sample taken at 3 times (concomitant with a visit performed in routine care):
For patients with ovarian cancer, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
For patients with a borderline ovarian tumor, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of the Receiver Operating Curve (ROC) | Identifying a signature of ovarian cancer diagnosis by analysis of coding and non-coding RNAs in the saliva of subjects | Through the end of study inclusions, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI and/or blood tumour markers) and requiring surgical management in routine care.
The patients concerned by the study already benefit from a surgical management in different gynecology-obstetrics/gynecological oncology departments in France, Canada and Tunisia, as well as from a validation of the therapeutic indications in accordance with the national practices in force.
The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations (imaging and/or blood tumour markers) necessary according to the context which are carried out according to the national and/or international recommendations in force.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen | Caen | Calvados | 14000 | France | ||
| CGFL |
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Saliva
|
| Dijon |
| Côte d'Or |
| 21079 |
| France |
| Institut Bergonié | Bordeaux | Gironde | 33076 | France |
| CHU Strasbourg | Strasbourg | Haut-Rhin | 67200 | France |
| CHU Toulouse | Toulouse | Haute-Garonne | 31059 | France |
| CHP St Grégoire | Saint-Grégoire | Ille Et Villaine | 35760 | France |
| Hôpital BICETRE | Le Kremlin-Bicêtre | Val de Marne | 94275 | France |
| Institut Gustave Roussy | Villejuif | Val de Marne | 94805 | France |
| CHU Angers | Angers | 49933 | France |
| CH Bastia | Bastia | 20600 | France |
| CHU Lyon Sud / Hospices Civils de Lyon | Lyon | 69000 | France |
| Centre Antoine Lacassagne | Nice | France |
| CH Niort | Niort | 79021 | France |
| CHU Tenon | Paris | 75020 | France |
| CHU Rennes | Rennes | 35000 | France |
| Clinique La sagesse | Rennes | France |
| CHU Rouen, Hôpital de Bois-Guillaume | Rouen | France |
| Clinique Pasteur | Toulouse | France |
| CHRU Bretonneau-Tours | Tours | 37044 | France |
| Universitätsklinik für Frauenheilkunde | Bern | 03010 | Switzerland |
| Centre de Maternité et de Néonatologie Wassila Bourguiba | Tunis | 01007 | Tunisia |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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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