Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
NCT ID: NCT06392997
Last Updated: 2025-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2500 participants
OBSERVATIONAL
2024-12-05
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Symptomatic group
Clinically symptomatic females with one or more of the following gynecological pathology:
* Endometriosis,
* Adenomyosis,
* Ovarian cysts,
* Fibroids,
* Ovarian cancer,
* Cervical cancer
* Uterine cancer.
Saliva sample
Saliva sample
Asymptomatic group
Asymptomatic females with:
* Cervical dysplasia or cancer
* A normal pap-smear (control)
Saliva sample
Saliva sample
Interventions
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Saliva sample
Saliva sample
Eligibility Criteria
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Inclusion Criteria
2. Subject (and if applicable her legal representative) having dated and signed the informed consent form
3. Subject with a medical insurance policy
4. Subject presenting to the department:
1. 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):
* Endometriosis
* Adenomyosis,
* Ovarian cysts,
* Fibroids,
* Ovarian cancer,
* Cervical cancer,
* Uterine cancer.
2. Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment.
3. Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context.
Exclusion Criteria
2. Known active oral or digestive mycosis
3. Evolving oral pathology, symptomatic or obvious
4. Known pregnancy
5. Known current non-gynecological pelvic pathology
6. Subject with a diagnosed breast cancer or cancer other than gynecological with the exception of basal cell carcinoma
7. Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma
8. Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion
9. Subject with significant difficulties reading or writing her language
10. Subject unable to comply with study and/or follow-up procedures
11. Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.
18 Years
FEMALE
Yes
Sponsors
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Monitoring Force Group
INDUSTRY
ZIWIG
INDUSTRY
Responsible Party
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Locations
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CHU d'Angers
Angers, , France
Clinique Tivoli Ducos - IFEMENDO
Bordeaux, , France
Institut Bergonié
Bordeaux, , France
CHU Caen
Caen, , France
CGFL
Dijon, , France
CHU Lyon Sud
Lyon, , France
American Hospital of Paris
Neuilly-sur-Seine, , France
CHU de Rennes Site Hôpital Sud
Rennes, , France
Clinique La sagesse
Rennes, , France
CHU Rouen
Rouen, , France
Clinique Pasteur
Toulouse, , France
CHU Bretonneau-Tours
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZWG-24-01
Identifier Type: -
Identifier Source: org_study_id
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