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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Hyperplasia
• Endometrial Hyperplasia Without Atypia
• Endometrial Neoplasms
• Estrogen Receptor
• Hyperplasia
• Peripheral Blood Mononuclear Cells
• Postmenopause

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