Endometrial PolypNCT04706000
Autophagy Markers in Endometrial Polyps
An observational study of Endometrial Polyp and Autophagy, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this research is to evaluate autophagy markers in patients with endometrial polyps Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Polyp, Autophagy
- What is being tested?
- Beclin 1 gene
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2021to 1 Feb 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with histopathologically proven endometrial polyp and healthy controls
Who may be able to join
- Patients over 35 years of age with a histopathologically confirmed diagnosis of endometrial polyp
- patients over the age of 35 whose histopathologically reported normal endometrial biopsy results.
Who cannot join
- Are under the age of 35,
- those with cognitive dysfunction,
- diagnosed with any type of cancer
- who are under treatment for cancer,
- diabetes mellitus,
- hypertension,
Show all 11Show fewer
- endometriosis,
- adenomyosis,
- chronic endometritis,
- have an acute or chronic illness,
- patients who have smoked and used alcohol in the last 10 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Faculty of Medicine
Muğla, 48000
About this study
Official title: Investigation of Autophagy Markers in Endometrial Polyps
The aim of this research is to evaluate autophagy markers in patients with endometrial polyps
Read the detailed description
Endometrial polyp are benign formations that are frequently encountered in gynecology practice and have malignant potential. It may be asymptomatic in the clinic or may present with abnormal uterine bleeding. Although its pathophysiology has not been clearly revealed, there are many studies in the literature about it. However, the autophagy pathway emerges as a subject that has never been evaluated. In this study, the investigators would like to prospectively evaluate Beclin 1, LC3A / B and p62 markers in the autophagy pathway in endometrial polyp tissue samples by immunohistochemistry and reveal their importance.
- Conditions
- Endometrial Polyp, Autophagy
- Being tested
- Beclin 1 gene
- Keywords
- polyp, endometrium, beclin 1, LC3, p62
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclin 1 geneGenetic
Also called LC3-II gene, p62 gene
The determination of Beclin 1, LC3-II and p62 genes, which are evaluated by immunohistochemistry, at the protein level will be done by ELISA method in MSKU Medical Faculty Medical Biology Laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Study group | endometrial polyp Receives: Genetic: Beclin 1 gene | |
| Control group | normal endometrium Receives: Genetic: Beclin 1 gene |
What is being measured
The primary outcome is the main question the study is designed to answer.
autophagy marker
Beclin 1 gene level
Measured: through study completion, an average of 1 year
autophagy marker
LC3II gene level
Measured: through study completion, an average of 1 year
autophagy marker
p62 gene level
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 posted12 Jan 2021
- Study start8 Jan 2021
- Primary completion8 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Endometrial PolypStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Sezgin, Muğla Sıtkı Koçman University
- Investigators
- Burak SEZGİN, MD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706000
- Sponsor's protocol ID
- 03.09.20-08/01
- Status last verified
- Dec 2023
- First submitted
- 8 Jan 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When we conducted the study, we will plan to make individual participant data (IPD) available to other researchers.
Publications
Zhang J. Teaching the basics of autophagy and mitophagy to redox biologists--mechanisms and experimental approaches. Redox Biol. 2015;4:242-59. doi: 10.1016/j.redox.2015.01.003. Epub 2015 Jan 13.
PubMed 25618581Zhan L, Yao S, Sun S, Su Q, Li J, Wei B. NLRC5 and autophagy combined as possible predictors in patients with endometriosis. Fertil Steril. 2018 Oct;110(5):949-956. doi: 10.1016/j.fertnstert.2018.06.028.
PubMed 30316442Xie Z, Klionsky DJ. Autophagosome formation: core machinery and adaptations. Nat Cell Biol. 2007 Oct;9(10):1102-9. doi: 10.1038/ncb1007-1102.
PubMed 17909521Wong M, Crnobrnja B, Liberale V, Dharmarajah K, Widschwendter M, Jurkovic D. The natural history of endometrial polyps. Hum Reprod. 2017 Feb;32(2):340-345. doi: 10.1093/humrep/dew307. Epub 2016 Dec 18.
PubMed 27994000Zhang L, Liu Y, Xu Y, Wu H, Wei Z, Cao Y. The expression of the autophagy gene beclin-1 mRNA and protein in ectopic and eutopic endometrium of patients with endometriosis. Int J Fertil Steril. 2015 Jan-Mar;8(4):429-36. doi: 10.22074/ijfs.2015.4183. Epub 2015 Feb 7.
PubMed 25780525
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Autophagy Markers in Endometrial Polyps
- ClinicalTrials.gov ID
- NCT04706000
- Acronym / sponsor ID
- 03.09.20-08/01
- Conditions
- Endometrial Polyp, Autophagy
- Keywords
- polyp, endometrium, beclin 1, LC3, p62
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 8 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 12 Jan 2021 (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.
The aim of this research is to evaluate autophagy markers in patients with endometrial polyps
Detailed description
Endometrial polyp are benign formations that are frequently encountered in gynecology practice and have malignant potential. It may be asymptomatic in the clinic or may present with abnormal uterine bleeding. Although its pathophysiology has not been clearly revealed, there are many studies in the literature about it. However, the autophagy pathway emerges as a subject that has never been evaluated. In this study, the investigators would like to prospectively evaluate Beclin 1, LC3A / B and p62 markers in the autophagy pathway in endometrial polyp tissue samples by immunohistochemistry and reveal their importance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Genetic: Beclin 1 geneendometrial polyp |
| Control group | – | Genetic: Beclin 1 genenormal endometrium |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histopathologically proven endometrial polyp and healthy controls
Key inclusion criteria (2 listed)
- Patients over 35 years of age with a histopathologically confirmed diagnosis of endometrial polyp
- patients over the age of 35 whose histopathologically reported normal endometrial biopsy results.
Key exclusion criteria (11 listed)
- Are under the age of 35,
- those with cognitive dysfunction,
- diagnosed with any type of cancer
- who are under treatment for cancer,
- diabetes mellitus,
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 |
|---|---|---|
| Beclin 1 geneAlso: LC3-II gene, p62 geneThe determination of Beclin 1, LC3-II and p62 genes, which are evaluated by immunohistochemistry, at the protein level will be done by ELISA method in MSKU Medical Faculty Medical Biology Laboratory. | Genetic | Control group, Study group |
Primary outcome
autophagy marker
Time frame: through study completion, an average of 1 year
Beclin 1 gene level
autophagy marker
Time frame: through study completion, an average of 1 year
LC3II gene level
autophagy marker
Time frame: through study completion, an average of 1 year
p62 gene level
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 6 Dec 2023.
- Background: PubMed 25618581Zhang J. Teaching the basics of autophagy and mitophagy to redox biologists--mechanisms and experimental approaches. Redox Biol. 2015;4:242-59. doi: 10.1016/j.redox.2015.01.003. Epub 2015 Jan 13.
- Background: PubMed 30316442Zhan L, Yao S, Sun S, Su Q, Li J, Wei B. NLRC5 and autophagy combined as possible predictors in patients with endometriosis. Fertil Steril. 2018 Oct;110(5):949-956. doi: 10.1016/j.fertnstert.2018.06.028.
- Background: PubMed 17909521Xie Z, Klionsky DJ. Autophagosome formation: core machinery and adaptations. Nat Cell Biol. 2007 Oct;9(10):1102-9. doi: 10.1038/ncb1007-1102.
- Background: PubMed 27994000Wong M, Crnobrnja B, Liberale V, Dharmarajah K, Widschwendter M, Jurkovic D. The natural history of endometrial polyps. Hum Reprod. 2017 Feb;32(2):340-345. doi: 10.1093/humrep/dew307. Epub 2016 Dec 18.
- Results publication: PubMed 25780525Zhang L, Liu Y, Xu Y, Wu H, Wei Z, Cao Y. The expression of the autophagy gene beclin-1 mRNA and protein in ectopic and eutopic endometrium of patients with endometriosis. Int J Fertil Steril. 2015 Jan-Mar;8(4):429-36. doi: 10.22074/ijfs.2015.4183. Epub 2015 Feb 7.
- Individual participant dataSharing planned: Undecided. When we conducted the study, we will plan to make individual participant data (IPD) available to other researchers.
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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.
Burak SEZGİN, MD principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Polyp and Autophagy, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 2 inclusion and 11 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
autophagy marker (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04706000, which also lists 5 linked publications.
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 6 Dec 2023.