Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes
Receptivity of Endometrial Tissue and Peripheral Blood Mononuclear Cells in the Pathogenetic Rationale for the Management of Postmenopause Patients With Endometrial Proliferative Processes
1 other identifier
observational
92
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2012
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 24, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedNovember 15, 2023
October 1, 2023
9.8 years
October 24, 2023
November 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
endometrial tissue and peripheral blood mononuclear cells receptivity
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
through study completion, an average of 1 year
Study Arms (4)
endometrial polyp
pathology according to histological examination
endometrial hyperplasia without atypia
pathology according to histological examination
atypical endometrial hyperplasia
pathology according to histological examination
endometrial cancer
pathology according to histological examination
Interventions
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.
Eligibility Criteria
The study included 92 patients with endometrial proliferative processes: endometrial polyp - 37, endometrial hyperplasia without atypia - 7, atypical endometrial hyperplasia - 8, endometrial cancer - 40
You may qualify if:
- endometrial polyps
- endometrial hyperplasia
- atypical endometrial hyperplasia
- endometrial cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dina Gutorova, PhD
Pirogov Russian National Research Medical University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2023
First Posted
November 3, 2023
Study Start
October 1, 2012
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
November 15, 2023
Record last verified: 2023-10