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| Name | Class |
|---|---|
| Monitoring Force Group | INDUSTRY |
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GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva.
The study population consists of patients with clinically symptomatic females with one or more of the gynecological pathologies (endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian/cervical/uterine cancer) and asymptomatic females.
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 necessary according to the context, which are carried out according to the local recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic group | Clinically symptomatic females with one or more of the following gynecological pathology:
|
| |
| Asymptomatic group | Asymptomatic females with:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saliva sample | Diagnostic Test | Saliva sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of the Receiver Operating Curve (ROC) | Identify a diagnostic signature for each pathology (Endometriosis / Adenomyosis / Ovarian cysts / Fibroids / Cervical Displasia / Ovarian cancer / Cervical cancer /Uterine cancer) by analyzing of coding and non-coding RNA contained in the saliva. | Through the end of study inclusions, an average of 1 year |
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Inclusion Criteria:
Subject of legal age (according to local legislation) and at least 18 years old
Subject (and if applicable her legal representative) having dated and signed the informed consent form
Subject with a medical insurance policy
Subject presenting to the department:
With Symptoms (bleeding and/or pain and/or clinically observed symptom) of one or more of the following pathologies (suspected undergoing diagnostic surgery/biopsy or diagnosed and before any curative treatment of the pathology):
Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment.
Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context.
Exclusion Criteria:
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The study populations is constituted of s:
Clinically symptomatic females with one or more of the following gynecological pathology:
Asymptomatic females with:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofiane Bendifallah, MD | Contact | +33146412699 | sofiane.bendifallah@yahoo.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Not yet recruiting | Angers | France |
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Salivary samples
| Clinique Tivoli Ducos - IFEMENDO | Recruiting | Bordeaux | France |
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| Institut Bergonié | Not yet recruiting | Bordeaux | France |
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| CHU Caen | Recruiting | Caen | 14033 | France |
|
| CGFL | Not yet recruiting | Dijon | France |
|
| CHU Lyon Sud | Not yet recruiting | Lyon | France |
|
| American Hospital of Paris | Not yet recruiting | Neuilly-sur-Seine | France |
|
| CHU de Rennes Site Hôpital Sud | Not yet recruiting | Rennes | France |
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| Clinique La sagesse | Not yet recruiting | Rennes | France |
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| CHU Rouen | Recruiting | Rouen | France |
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| Clinique Pasteur | Recruiting | Toulouse | France |
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| CHU Bretonneau-Tours | Recruiting | Tours | France |
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| Institut Gustave Roussy | Not yet recruiting | Villejuif | France |
|
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D004715 | Endometriosis |
| D010051 | Ovarian Neoplasms |
| D010048 | Ovarian Cysts |
| D007889 | Leiomyoma |
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D003560 | Cysts |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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