Clinical trial NCT06115577: Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes
Official title: Receptivity of Endometrial Tissue and Peripheral Blood Mononuclear Cells in the Pathogenetic Rationale for the Management of Postmenopause Patients With Endometrial Proliferative Processes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Hyperplasia Without Atypia
Endometrial Hyperplasia With Atypia
Endometrial Cancer
Peripheral Blood Mononuclear Cells
Postmenopause
Estrogen Receptor
Progesterone Receptor
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 92
Sex: FEMALE
Minimum age (years): 53
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 92 patients with endometrial proliferative processes: endometrial polyp - 37, endometrial hyperplasia without atypia - 7, atypical endometrial hyperplasia - 8, endometrial cancer - 40

Brief summary: A prospective observational study of endometrial tissue and peripheral blood mononuclear cells receptivity to sex steroid hormones in postmenopausal patients with endometrial proliferative processes

Detailed description: Endometrial cancer is in third place among cancer diseases in female population of Russia. The peak morbidity occurs during the postmenopausal period. In this regard, early diagnosis of previous endometrial proliferative processes and effective methods for their treatment are relevant. However, failures with hormonal therapy are often observed. This may be due to the low receptivity of the pathological tissue. It is also known that the functional activity of immunocompetent cells is controlled by the immune system, however, studies of the receptivity of peripheral blood mononuclear cells to sex steroid hormones were carried out in healthy blood donors. Changes in mononuclear cells receptivity may be one of the pathogenetic links in the development of endometrial proliferative processes and endometrial cancer. This may also influence the effectiveness of their treatment. In this regard, the purpose of the study is to evaluate the role of the expression of estradiol and progesterone receptor genes in endometrial tissue and peripheral blood mononuclear cells in the occurrence of endometrial proliferative processes in postmenopausal patients with a pathogenetic justification for the choice of treatment method. To achieve this goal, the investigators investigated the expression level of estrogen and progesterone receptors (ERa, ERb, GPER, PRA, PRB, mPR, PGRmC1) by RT-PCR in pathological endometrial tissue and peripheral blood mononuclear cells. GABDH was used as a comparison gene. The data obtained made it possible to determine the significance of mononuclear cell receptivity in the pathogenesis of endometrial proliferative processes.

Eligibility criteria: Inclusion Criteria:

* endometrial polyps
* endometrial hyperplasia
* atypical endometrial hyperplasia
* endometrial cancer

Exclusion Criteria:

* hormonal treatment (estrogen-progestogens, gestagens, gonadotropin-releasing hormone agonists, menopausal hormone therapy and tamoxifen) for 6 months before the study
* uterine fibroids, larger than 6-7 pregnancy weeks
* pathology of the uterine appendages according to ultrasound pelvis
* inflammatory diseases of various localization at the time of taking the material

Primary outcomes:
measure: endometrial tissue and peripheral blood mononuclear cells receptivity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Dina Gutorova, PhD
role: PRINCIPAL_INVESTIGATOR
References: