Evaluation of Genetic Signature in Endometriosis Disease by Non Invasive Sampling

NCT ID: NCT06100471

Last Updated: 2024-02-20

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

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-12-31

Brief Summary

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Endometriosis is a disease that affects 10-15% of the general population and 50% of infertile women. It is characterized by the presence of endometrial tissue outside the uterine cavity. Endometriosis can lead to infertility by interfering through endocrine and mechanical alterations on the function of the ovaries, fallopian tubes, and uterus. The aim of the study is to define the differential expression of a cluster of RNAs tissue driven for the identification of an RNA profile in saliva, specific for endometriosis. This study focuses on the expression of genes involved in the control and regulation of apoptosis, cell survival, metabolism, cell adhesion and invasion, angiogenesis, inflammation, and estrogen receptor expression levels.

Detailed Description

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Retrospective selection based on anamnestic criteria of: 50 patients with diagnosed endometriotic adnexal pathology (case, CA), 50 patients with non-endometriotic adnexal pathology (control, CO) and 50 patients with no gynecological pathology, not undergoing surgery (analytical control).

The study involves collecting a saliva sample from all patients involved in the study, and performing a biopsy from both patients with endometriotic adnexal pathology (CA) and patients with non-endometriotic adnexal pathology (CO).

Conditions

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Endometriosis Hypofertility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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case

Patients with endometriotic adnexal pathology

Observational study

Intervention Type OTHER

Observational study in different tissues in identifing new genetic markers related to endometriosis disease

control

Patients with non endometriotic adnexal pathology

Observational study

Intervention Type OTHER

Observational study in different tissues in identifing new genetic markers related to endometriosis disease

analytical control

Patients with no gynecological pathology, not undergoing surgery

Observational study

Intervention Type OTHER

Observational study in different tissues in identifing new genetic markers related to endometriosis disease

Interventions

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Observational study

Observational study in different tissues in identifing new genetic markers related to endometriosis disease

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Case population (CA), patients with endometriotic adnexal pathology
* Control population (CO), patients with non-endometriotic adnexal pathology
* Analytical control population (C-), patients with no gynecologic pathology, not undergoing surgery

Exclusion Criteria

* Women with ages outside the inclusion range
* Pregnant patient
* Patient with a personal history of cancer
* Patient infected with HIV
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eurofins Genoma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eurofins Genoma

Rome, , Italy

Site Status

Countries

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Italy

References

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Dabi Y, Suisse S, Puchar A, Delbos L, Poilblanc M, Descamps P, Haury J, Golfier F, Jornea L, Bouteiller D, Touboul C, Darai E, Bendifallah S. Endometriosis-associated infertility diagnosis based on saliva microRNA signatures. Reprod Biomed Online. 2023 Jan;46(1):138-149. doi: 10.1016/j.rbmo.2022.09.019. Epub 2022 Sep 27.

Reference Type BACKGROUND
PMID: 36411203 (View on PubMed)

Bendifallah S, Dabi Y, Suisse S, Jornea L, Bouteiller D, Touboul C, Puchar A, Darai E. A Bioinformatics Approach to MicroRNA-Sequencing Analysis Based on Human Saliva Samples of Patients with Endometriosis. Int J Mol Sci. 2022 Jul 21;23(14):8045. doi: 10.3390/ijms23148045.

Reference Type BACKGROUND
PMID: 35887388 (View on PubMed)

Bendifallah S, Suisse S, Puchar A, Delbos L, Poilblanc M, Descamps P, Golfier F, Jornea L, Bouteiller D, Touboul C, Dabi Y, Darai E. Salivary MicroRNA Signature for Diagnosis of Endometriosis. J Clin Med. 2022 Jan 26;11(3):612. doi: 10.3390/jcm11030612.

Reference Type BACKGROUND
PMID: 35160066 (View on PubMed)

Bendifallah S, Dabi Y, Suisse S, Jornea L, Bouteiller D, Touboul C, Puchar A, Darai E. MicroRNome analysis generates a blood-based signature for endometriosis. Sci Rep. 2022 Mar 8;12(1):4051. doi: 10.1038/s41598-022-07771-7.

Reference Type BACKGROUND
PMID: 35260677 (View on PubMed)

Dabi Y, Suisse S, Jornea L, Bouteiller D, Touboul C, Puchar A, Darai E, Bendifallah S. Clues for Improving the Pathophysiology Knowledge for Endometriosis Using Plasma Micro-RNA Expression. Diagnostics (Basel). 2022 Jan 12;12(1):175. doi: 10.3390/diagnostics12010175.

Reference Type BACKGROUND
PMID: 35054341 (View on PubMed)

Bendifallah S, Puchar A, Suisse S, Delbos L, Poilblanc M, Descamps P, Golfier F, Touboul C, Dabi Y, Darai E. Machine learning algorithms as new screening approach for patients with endometriosis. Sci Rep. 2022 Jan 12;12(1):639. doi: 10.1038/s41598-021-04637-2.

Reference Type BACKGROUND
PMID: 35022502 (View on PubMed)

Other Identifiers

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01-23

Identifier Type: -

Identifier Source: org_study_id

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