Evaluation of Genetic Signature in Endometriosis Disease by Non Invasive Sampling (niEndometriosi)

Eurofins

Status: Invitation-only

Conditions: Endometriosis; Hypofertility

Treatments: Other: Observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT06100471

01-23

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

case

Description:

Patients with endometriotic adnexal pathology

Treatment:

Other: Observational study

control

Description:

Patients with non endometriotic adnexal pathology

Treatment:

Other: Observational study

analytical control

Description:

Patients with no gynecological pathology, not undergoing surgery

Treatment:

Other: Observational study