Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology

NCT ID: NCT06392997

Last Updated: 2025-01-23

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-05

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Disease Gynecologic Cancer Endometriosis Ovarian Cancer Cyst Ovary Fibroid Cervical Cancer Uterine Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Saliva sample

Asymptomatic group

Asymptomatic females with:

* Cervical dysplasia or cancer
* A normal pap-smear (control)

Saliva sample

Intervention Type DIAGNOSTIC_TEST

Saliva sample

Interventions

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Saliva sample

Saliva sample

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Subject of legal age (according to local legislation) and at least 18 years old
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

1. Recent (\<1 month) or ongoing bacterial or viral infection
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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Monitoring Force Group

INDUSTRY

Sponsor Role collaborator

ZIWIG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU d'Angers

Angers, , France

Site Status NOT_YET_RECRUITING

Clinique Tivoli Ducos - IFEMENDO

Bordeaux, , France

Site Status RECRUITING

Institut Bergonié

Bordeaux, , France

Site Status NOT_YET_RECRUITING

CHU Caen

Caen, , France

Site Status RECRUITING

CGFL

Dijon, , France

Site Status NOT_YET_RECRUITING

CHU Lyon Sud

Lyon, , France

Site Status NOT_YET_RECRUITING

American Hospital of Paris

Neuilly-sur-Seine, , France

Site Status NOT_YET_RECRUITING

CHU de Rennes Site Hôpital Sud

Rennes, , France

Site Status NOT_YET_RECRUITING

Clinique La sagesse

Rennes, , France

Site Status NOT_YET_RECRUITING

CHU Rouen

Rouen, , France

Site Status RECRUITING

Clinique Pasteur

Toulouse, , France

Site Status RECRUITING

CHU Bretonneau-Tours

Tours, , France

Site Status RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Sofiane Bendifallah, MD

Role: CONTACT

+33146412699

Facility Contacts

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Léa DELBOS, Dr

Role: primary

+33 2 41 76 28 62

Horace ROMAN, Pr

Role: primary

+33 5 64 10 09 45

Frédéric GUYON, Dr

Role: primary

+33 5 56 33 32 79

Raffaèle Fauvet, Pr

Role: primary

+33 2 31 27 23 36

Hélène COSTAZ, Dr

Role: primary

+33 6 66 35 55 33

François GOLFIER, Pr

Role: primary

+33 4 78 86 41 78

Sofiane Bendifallah, MD

Role: primary

+33146412699

Vincent LAVOUE, Pr

Role: primary

+33 2 99 28 43 21

Claire Marie ROGER, Dr

Role: primary

+33 2 99 85 75 14

Morgane PERRIN, Dr

Role: primary

+33 2 32 88 89 90

Ludivine Genre, Dr

Role: primary

+33 5 62 21 39 49

Lobna OULDAMER, Pr

Role: primary

+33 2 47 47 47 41

Alexandra LEARY, Dr

Role: primary

+33 1 42 11 43 77

Other Identifiers

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ZWG-24-01

Identifier Type: -

Identifier Source: org_study_id

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