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

NCT ID: NCT06115577

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-01
• Study Completion Date: 2022-08-01

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.

Conditions

Endometrial Hyperplasia Without Atypia; Endometrial Hyperplasia With Atypia; Endometrial Cancer; Peripheral Blood Mononuclear Cells; Postmenopause; Estrogen Receptor; Progesterone Receptor

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

endometrial polyp

pathology according to histological examination

endometrial tissue and peripheral blood mononuclear cells receptivity

Intervention Type: DIAGNOSTIC_TEST

Participants investigated the expression level of estrogen and progesterone receptors (ERα, ERβ, GPER, PRA, PRB, mPR, PGRmC1) by RT-PCR in pathological endometrial tissue and peripheral blood mononuclear cells. GABDH was used as a comparison gene.

endometrial hyperplasia without atypia

pathology according to histological examination

endometrial tissue and peripheral blood mononuclear cells receptivity

Intervention Type: DIAGNOSTIC_TEST

Participants investigated the expression level of estrogen and progesterone receptors (ERα, ERβ, GPER, PRA, PRB, mPR, PGRmC1) by RT-PCR in pathological endometrial tissue and peripheral blood mononuclear cells. GABDH was used as a comparison gene.

atypical endometrial hyperplasia

pathology according to histological examination

endometrial tissue and peripheral blood mononuclear cells receptivity

Intervention Type: DIAGNOSTIC_TEST

Participants investigated the expression level of estrogen and progesterone receptors (ERα, ERβ, GPER, PRA, PRB, mPR, PGRmC1) by RT-PCR in pathological endometrial tissue and peripheral blood mononuclear cells. GABDH was used as a comparison gene.

endometrial cancer

pathology according to histological examination

endometrial tissue and peripheral blood mononuclear cells receptivity

Intervention Type: DIAGNOSTIC_TEST

Participants investigated the expression level of estrogen and progesterone receptors (ERα, ERβ, GPER, PRA, PRB, mPR, PGRmC1) by RT-PCR in pathological endometrial tissue and peripheral blood mononuclear cells. GABDH was used as a comparison gene.

Interventions

endometrial tissue and peripheral blood mononuclear cells receptivity

Participants investigated the expression level of estrogen and progesterone receptors (ERα, ERβ, GPER, PRA, PRB, mPR, PGRmC1) by RT-PCR in pathological endometrial tissue and peripheral blood mononuclear cells. GABDH was used as a comparison gene.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 53 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pirogov Russian National Research Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dina Gutorova, PhD

Role: PRINCIPAL_INVESTIGATOR

Pirogov Russian National Research Medical University

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

210

Identifier Type: -

Identifier Source: org_study_id