Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes

Completed

• Conditions: Endometrial Hyperplasia Without Atypia; Endometrial Hyperplasia With Atypia; Postmenopause; Progesterone Receptor; Endometrial Cancer; Peripheral Blood Mononuclear Cells; Estrogen Receptor
• Interventions: Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivity

• Registration Number: NCT06115577
• Lead Sponsor: Pirogov Russian National Research Medical University

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.

Study Timeline

• Study Start: 2012-10-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-29
• Study First Posted: 2023-11-03
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
endometrial polyp	endometrial tissue and peripheral blood mononuclear cells receptivity	pathology according to histological examination
atypical endometrial hyperplasia	endometrial tissue and peripheral blood mononuclear cells receptivity	pathology according to histological examination
endometrial cancer	endometrial tissue and peripheral blood mononuclear cells receptivity	pathology according to histological examination
endometrial hyperplasia without atypia	endometrial tissue and peripheral blood mononuclear cells receptivity	pathology according to histological examination

Primary Outcome Measures

Name	Time	Method
endometrial tissue and peripheral blood mononuclear cells receptivity	through study completion, an average of 1 year	Expression level of ERα, ERβ, GPER, PRA, PRB, mPR, PGRmC1 in endometrial tissue and peripheral blood mononuclear cells in patients with endometrial polyps, endometrial hyperplasia, atypical endometrial hyperplasia, endometrial cancer