Endometrial Hyperplasia Without AtypiaNCT06115577
Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes
An observational study of Endometrial Hyperplasia Without Atypia and Endometrial Hyperplasia With Atypia, run by Pirogov Russian National Research Medical University.
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 Read more about this study
- Who is it for?
- Ages 53 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Hyperplasia Without Atypia, Endometrial Hyperplasia With Atypia, Endometrial Cancer
- What is being tested?
- endometrial tissue and peripheral blood mononuclear cells receptivity
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2012to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 53 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included 92 patients with endometrial proliferative processes: endometrial polyp - 37, endometrial hyperplasia without atypia - 7, atypical endometrial hyperplasia - 8, endometrial cancer - 40
Who may be able to join
- endometrial polyps
- endometrial hyperplasia
- atypical endometrial hyperplasia
- endometrial cancer
Who cannot join
- 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
About this study
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
A prospective observational study of endometrial tissue and peripheral blood mononuclear cells receptivity to sex steroid hormones in postmenopausal patients with endometrial proliferative processes
Read the 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
- Being tested
- endometrial tissue and peripheral blood mononuclear cells receptivity
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial tissue and peripheral blood mononuclear cells receptivityDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| endometrial polyp | pathology according to histological examination Receives: Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivity | |
| endometrial hyperplasia without atypia | pathology according to histological examination Receives: Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivity | |
| atypical endometrial hyperplasia | pathology according to histological examination Receives: Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivity | |
| endometrial cancer | pathology according to histological examination Receives: Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Oct 2012
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Hyperplasia Without AtypiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dina Gutorova, PhD, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115577
- Sponsor's protocol ID
- 210
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06115577
- Acronym / sponsor ID
- 210
- Conditions
- Endometrial Hyperplasia Without Atypia, Endometrial Hyperplasia With Atypia, Endometrial Cancer, Peripheral Blood Mononuclear Cells, Postmenopause, Estrogen Receptor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| endometrial polyp | – | Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivitypathology according to histological examination |
| endometrial hyperplasia without atypia | – | Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivitypathology according to histological examination |
| atypical endometrial hyperplasia | – | Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivitypathology according to histological examination |
| endometrial cancer | – | Diagnostic Test: endometrial tissue and peripheral blood mononuclear cells receptivitypathology according to histological examination |
Who may qualify
- Ages
- 53 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 92 patients with endometrial proliferative processes: endometrial polyp - 37, endometrial hyperplasia without atypia - 7, atypical endometrial hyperplasia - 8, endometrial cancer - 40
Key inclusion criteria (4 listed)
- endometrial polyps
- endometrial hyperplasia
- atypical endometrial hyperplasia
- endometrial cancer
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endometrial tissue and peripheral blood mononuclear cells receptivityParticipants 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. | Diagnostic test | atypical endometrial hyperplasia, endometrial cancer, endometrial hyperplasia without atypia, endometrial polyp |
Primary outcome
endometrial tissue and peripheral blood mononuclear cells receptivity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Related trials for Endometrial Hyperplasia Without Atypia
Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer
Atypical Endometrial Hyperplasia, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
Active, not recruitingPhase 2
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy
Atypical Endometrial Hyperplasia, Endometrial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Gutorova, PhD principal investigator
Pirogov Russian National Research Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Hyperplasia Without Atypia and Endometrial Hyperplasia With Atypia, run by Pirogov Russian National Research Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial tissue and peripheral blood mononuclear cells receptivity (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.