The Effect of Androgen Receptor Polymorphism on Endometrial Cancer
NCT ID: NCT05157373
Last Updated: 2021-12-15
Study Results
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Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2022-04-01
2024-04-01
Brief Summary
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The androgens, through their receptors, decrease the proliferation of the endometrial cells. After menopause, the number of androgens receptors (ARs) increases in proportion to estrogen receptors and this may lead to endometrial atrophy. If the functionality of ARs is decreased, the effect of estrogen increases and this may possibly lead to endometrial hyperplasia or to endometrial cancer. The AR gene is located on the X chromosome and consists of 8 exons. Genetic research has shown that on exon 1, there is an area of trinucleotide Cytosine- Adenosine- Guanin (CAG) repeats which controls the functionality of the receptor. The more CAG repeats, the less responsive the receptor.
The goal of this research is to study the AR gene polymorphism and particularly the number of CAG repeats on exon 1, in patients with known endometrial pathology (benign and malignant). The results will be compared with a random sample of the general population without endometrial pathology.
Detailed Description
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The goal of this research is to study the AR gene polymorphism and particularly the number of CAG repeats on exon 1, in patients with known endometrial pathology (benign and malignant). The results will be compared with a random sample of the general population without endometrial pathology.
Impact on science, economy and society Adrenal receptor gene polymorphism seems to be related to many clinical conditions. Studying the AR gene polymorphism in relation to endometrial functionality will provide better understanding of the physiology of endometrial tissue function, the natural progression of endometrial lesions, as well as the potential of recurrence of those lesions after treatment. This may lead to the modification of therapeutic interventions and to the development of screening tests in high-risk populations.
Compliance Statement This study will be conducted in full accordance with all applicable research policies and procedures and all applicable laws and regulations. All episodes of noncompliance will be documented. The investigators will perform the study in accordance with this protocol, will obtain consent and assent, and will report unanticipated problems involving risks to subjects. Collection, recording, and reporting of data will be accurate and will ensure the privacy, health, and welfare of research subjects during and after the study.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Patients with any type of endometrial cancer
Endometrial sampling and Peripheral blood collection
The endometrial biopsy will be performed with a pipette. The pipelle will be inserted gently through the cervix and into the uterus. The pipelle procedure takes approximately one minute and involves gently moving the pipelle back and forth to obtain a sample. Then 10cc of peripheral blood will be collected.
FSFI Scale
The participants will fill up the Female Sexual Function Index (FSFI) questionnaire.
The FSFI is a 19-item self-report questionnaire designed to measure sexual functioning in women. It assesses six domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain (i.e., pain associated with vaginal penetration).
Group 2
Patients with hyperplastic endometrial lesion (all type of endometrial hyperplasia and endometrial polyps). In this group will be included the breast cancer survivors under tamoxifen.
Endometrial sampling and Peripheral blood collection
The endometrial biopsy will be performed with a pipette. The pipelle will be inserted gently through the cervix and into the uterus. The pipelle procedure takes approximately one minute and involves gently moving the pipelle back and forth to obtain a sample. Then 10cc of peripheral blood will be collected.
FSFI Scale
The participants will fill up the Female Sexual Function Index (FSFI) questionnaire.
The FSFI is a 19-item self-report questionnaire designed to measure sexual functioning in women. It assesses six domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain (i.e., pain associated with vaginal penetration).
Control group
A random sample of women without any endometrial pathology.
Endometrial sampling and Peripheral blood collection
The endometrial biopsy will be performed with a pipette. The pipelle will be inserted gently through the cervix and into the uterus. The pipelle procedure takes approximately one minute and involves gently moving the pipelle back and forth to obtain a sample. Then 10cc of peripheral blood will be collected.
FSFI Scale
The participants will fill up the Female Sexual Function Index (FSFI) questionnaire.
The FSFI is a 19-item self-report questionnaire designed to measure sexual functioning in women. It assesses six domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain (i.e., pain associated with vaginal penetration).
Interventions
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Endometrial sampling and Peripheral blood collection
The endometrial biopsy will be performed with a pipette. The pipelle will be inserted gently through the cervix and into the uterus. The pipelle procedure takes approximately one minute and involves gently moving the pipelle back and forth to obtain a sample. Then 10cc of peripheral blood will be collected.
FSFI Scale
The participants will fill up the Female Sexual Function Index (FSFI) questionnaire.
The FSFI is a 19-item self-report questionnaire designed to measure sexual functioning in women. It assesses six domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain (i.e., pain associated with vaginal penetration).
Eligibility Criteria
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Inclusion Criteria
2. Women with the following endometrial lesion:
1. Endometrial polyps
2. Endometrial hyperplasia with and without atypia
3. Endometrial hyperplasia after tamoxifen
3. Women with histologically proven normal endometrium
Exclusion Criteria
2. Women with triple negative breast cancer
3. Women unable to consent
18 Years
90 Years
FEMALE
Yes
Sponsors
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University of Nicosia
OTHER
Responsible Party
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Dionysis Vaidakis
Clinical Assistant Professor
Principal Investigators
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Maria Chryssi, MSh
Role: PRINCIPAL_INVESTIGATOR
Anticancer oncological hospital of Athens "St Savvas'
Dionysios Vaidakis, MD,PhD.
Role: STUDY_DIRECTOR
Department of Life & Health Sciences, University of Nicosia
Adonis Ioannides, MD,PhD.
Role: STUDY_CHAIR
Department of Life & Health Sciences, University of Nicosia
Central Contacts
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References
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Chuffa LG, Lupi-Junior LA, Costa AB, Amorim JP, Seiva FR. The role of sex hormones and steroid receptors on female reproductive cancers. Steroids. 2017 Feb;118:93-108. doi: 10.1016/j.steroids.2016.12.011. Epub 2016 Dec 29.
Sanderson PA, Critchley HO, Williams AR, Arends MJ, Saunders PT. New concepts for an old problem: the diagnosis of endometrial hyperplasia. Hum Reprod Update. 2017 Mar 1;23(2):232-254. doi: 10.1093/humupd/dmw042.
Maybin JA, Critchley HO. Menstrual physiology: implications for endometrial pathology and beyond. Hum Reprod Update. 2015 Nov-Dec;21(6):748-61. doi: 10.1093/humupd/dmv038. Epub 2015 Aug 7.
Zitzmann M, Nieschlag E. The CAG repeat polymorphism within the androgen receptor gene and maleness. Int J Androl. 2003 Apr;26(2):76-83. doi: 10.1046/j.1365-2605.2003.00393.x.
Qin Z, Li X, Han P, Zheng Y, Liu H, Tang J, Yang C, Zhang J, Wang K, Qi X, Tang M, Wang W, Zhang W. Association between polymorphic CAG repeat lengths in the androgen receptor gene and susceptibility to prostate cancer: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Jun;96(25):e7258. doi: 10.1097/MD.0000000000007258.
Mao Q, Qiu M, Dong G, Xia W, Zhang S, Xu Y, Wang J, Rong Y, Xu L, Jiang F. CAG repeat polymorphisms in the androgen receptor and breast cancer risk in women: a meta-analysis of 17 studies. Onco Targets Ther. 2015 Aug 13;8:2111-20. doi: 10.2147/OTT.S85130. eCollection 2015.
Student S, Hejmo T, Poterala-Hejmo A, Lesniak A, Buldak R. Anti-androgen hormonal therapy for cancer and other diseases. Eur J Pharmacol. 2020 Jan 5;866:172783. doi: 10.1016/j.ejphar.2019.172783. Epub 2019 Nov 8.
Rosenfield RL, Ehrmann DA. The Pathogenesis of Polycystic Ovary Syndrome (PCOS): The Hypothesis of PCOS as Functional Ovarian Hyperandrogenism Revisited. Endocr Rev. 2016 Oct;37(5):467-520. doi: 10.1210/er.2015-1104. Epub 2016 Jul 26.
Polat S, Karaburgu S, Unluhizarci K, Dundar M, Ozkul Y, Arslan YK, Karaca Z, Kelestimur F. The role of androgen receptor CAG repeat polymorphism in androgen excess disorder and idiopathic hirsutism. J Endocrinol Invest. 2020 Sep;43(9):1271-1281. doi: 10.1007/s40618-020-01215-7. Epub 2020 Mar 12.
Baculescu N. The role of androgen receptor activity mediated by the CAG repeat polymorphism in the pathogenesis of PCOS. J Med Life. 2013 Mar 15;6(1):18-25. Epub 2013 Mar 25.
Zhang T, Liang W, Fang M, Yu J, Ni Y, Li Z. Association of the CAG repeat polymorphisms in androgen receptor gene with polycystic ovary syndrome: a systemic review and meta-analysis. Gene. 2013 Jul 25;524(2):161-7. doi: 10.1016/j.gene.2013.04.040. Epub 2013 Apr 26.
Other Identifiers
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DV001
Identifier Type: -
Identifier Source: org_study_id