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

Sponsor

Pirogov Russian National Research Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT06115577

Collaborator

(none)

Enrollment

118

Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Endometrial Hyperplasia Without Atypia Endometrial Hyperplasia With Atypia Endometrial Cancer Peripheral Blood Mononuclear Cells Postmenopause Estrogen Receptor Progesterone Receptor	Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivity

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 Design

Study Type:

Observational

Actual Enrollment :

92 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Aug 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
endometrial polyp pathology according to histological examination	Diagnostic Test: 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.
endometrial hyperplasia without atypia pathology according to histological examination	Diagnostic Test: 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.
atypical endometrial hyperplasia pathology according to histological examination	Diagnostic Test: 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.
endometrial cancer pathology according to histological examination	Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

53 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

endometrial proliferative processes (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, gynecological diseases: 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pirogov Russian National Research Medical University

Investigators

Principal Investigator: Dina Gutorova, PhD, Pirogov Russian National Research Medical University

Study Documents (Full-Text)

Study Protocol - Oct 1, 2012

More Information

Publications

None provided.

Responsible Party:

Pirogov Russian National Research Medical University

ClinicalTrials.gov Identifier:

NCT06115577

Other Study ID Numbers:

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometrial Neoplasms

Endometrial Hyperplasia

Hyperplasia

Study Results

No Results Posted as of Nov 3, 2023