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NCT06115577 Clinical Trial

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

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06115577
Other study ID # 210
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2012
Est. completion date August 1, 2022

Study information
Verified date October 2023
Source Pirogov Russian National Research Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 53 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pirogov Russian National Research Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary endometrial tissue and peripheral blood mononuclear cells receptivity Expression level of ERa, ERß, 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 through study completion, an average of 1 year
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