Androgen Receptor AbnormalARECNCT05157373
The Effect of Androgen Receptor Polymorphism on Endometrial Cancer
An observational study of Androgen Receptor Abnormal and Endometrial Disorder, run by University of Nicosia.
Trial summary
Endometrial tissue is a hormonal-dependent tissue in both pre- and postmenopausal period. The endometrial cells are expressing receptors for all sex hormones, mainly for estrogen, progesterone and androgens. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Androgen Receptor Abnormal, Endometrial Disorder
- What is being tested?
- Endometrial sampling and Peripheral blood collection and FSFI Scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Apr 2024
- 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 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted at 2 investigative sites in Greece and Cyprus. Recruitment will stop when approximately 150 patients are enrolled. The study will be conducted at UNIC and will include patients from Anticancer Oncological Hospital of Athens ''Saint Savvas Hospital'' and from the researchers' private practices (control group and patients with benign endometrial lesions). All patients meeting the inclusion criteria below will be identified. Up to 150 selected cases from among eligible patients will be enrolled in the study protocol.
Who may be able to join
- Women with histologically diagnosed primary endometrial cancer. All stages of endometrial cancer patients can be included in this group.
- Women with the following endometrial lesion:
- Endometrial polyps
- Endometrial hyperplasia with and without atypia
- Endometrial hyperplasia after tamoxifen
- Women with histologically proven normal endometrium
Who cannot join
- Women with metastatic cancer in endometrium
- Women with triple negative breast cancer
- Women unable to consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Androgen Receptor Polymorphism on Endometrial Cancer Development, Progression, and Outcome
Endometrial tissue is a hormonal-dependent tissue in both pre- and postmenopausal period. The endometrial cells are expressing receptors for all sex hormones, mainly for estrogen, progesterone and androgens. The proper response of the endometrial cells on hormones is crucial for a well-balanced fluctuation of endometrial tissue. If, for any reason, these responses are altered, this may lead to benign or malignant lesions.
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.
Read the detailed description
The role of CAG repeats on the AR is well established in degenerative neurological diseases in prostate and breast cancer, but the corresponding role in endometrial benign or malignant lesions is not well studied. It seems that there is a gap in the international literature since the results of the published studies are conflicting. A meta-analysis of 51 studies published by Qin et al. in 2017, suggested that the carriers of short polymorphic CAG repeats might increase the risk of prostate cancer, and could be used as a potential detecting marker. Another meta-analysis of 17 studies concluded that the longest CAG repeats increase the risk of breast cancer. Both those cancers are testosterone dependent and the higher the testosterone serum levels, the greater the cancer risk. Among women, the highest testosterone serum levels are observed in polycystic ovarian syndrome (PCOS) patients. A study published in 2020 concluded that the risk of PCOS is associated with the inheritance of ARs with shorter CAG repeats.Even though a meta-analysis of 11 studies demonstrate no evident association between the CAG length in AR gene and PCOS risk, the CAG length appears to be positively associated with higher testosterone levels. However, larger scale case-control studies are needed to validate the results. The rationale of the present study is to contribute to the literature by correlating the number of CAG repeats on AR with specific endometrial benign or malignant lesions. This may result in a better understanding of the nature of endometrial lesions and the development of specific clinical interventions.
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
- Androgen Receptor Abnormal, Endometrial Disorder
- Being tested
- Endometrial sampling and Peripheral blood collection, FSFI Scale
- Keywords
- Androgen Receptor, CAG, Receptor polymorphism
- Medical subject headings
- Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial sampling and Peripheral blood collectionDiagnostic test
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 ScaleBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with any type of endometrial cancer Receives: Diagnostic Test: Endometrial sampling and Peripheral blood collection; Behavioral: FSFI Scale | |
| 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. Receives: Diagnostic Test: Endometrial sampling and Peripheral blood collection; Behavioral: FSFI Scale | |
| Control group | A random sample of women without any endometrial pathology. Receives: Diagnostic Test: Endometrial sampling and Peripheral blood collection; Behavioral: FSFI Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of CAG repeats on exon 1 of AR gene and the relation to endometrial cancer vs control group
DNA analysis is required for the CAG repeat testing procedure. The DNA will be isolated from venous white blood cells and from endometrial cells. The high-molecular-weight DNA will then be analysed by polymerase chain reaction (PCR) amplification protocols, the exon 1 of the androgen receptor gene will be located and the number of CAG repeats will be recorded. If PCR is not sufficient to determine the exact number of replicates per case, the nucleotide sequence of the PCR products will be determined.
Measured: Day 1
The length of CAG repeats on exon 1 of AR gene and the relation to benign lesions of the endometrium vs control group
DNA analysis is required for the CAG repeat testing procedure. The DNA will be isolated from venous white blood cells and from endometrial cells. The high-molecular-weight DNA will then be analyzed by PCR amplification protocols, the exon 1 of the androgen receptor gene will be located and the number of CAG repeats will be recorded. If PCR is not sufficient to determine the exact number of replicates per case, the nucleotide sequence of the PCR products will be determined.
Measured: Day 1
The length of CAG repeats on exon 1 of AR gene as a predictive factor for endometrial lesions
DNA analysis is required for the CAG repeat testing procedure. The DNA will be isolated from venous white blood cells and from endometrial cells. The high-molecular-weight DNA will then be analyzed by PCR amplification protocols, the exon 1 of the androgen receptor gene will be located and the number of CAG repeats will be recorded. If PCR is not sufficient to determine the exact number of replicates per case, the nucleotide sequence of the PCR products will be determined.
Measured: Day 1
Secondary outcomes (3)
The length of CAG repeats on exon 1 of AR gene and the relation to endometrial cancer stage at diagnosis among group 1 patients
DNA analysis is required for the CAG repeat testing procedure. The DNA will be isolated from venous white blood cells and from endometrial cells. The high-molecular-weight DNA will then be analyzed by PCR amplification protocols, the exon 1 of the androgen receptor gene will be located and the number of CAG repeats will be recorded. If PCR is not sufficient to determine the exact number of replicates per case, the nucleotide sequence of the PCR products will be determined.
Measured: Day 1
The length of CAG repeats on exon 1 of AR gene and the relation to endometrial cancer type among group 1 patients
DNA analysis is required for the CAG repeat testing procedure. The DNA will be isolated from venous white blood cells and from endometrial cells. The high-molecular-weight DNA will then be analyzed by PCR amplification protocols, the exon 1 of the androgen receptor gene will be located and the number of CAG repeats will be recorded. If PCR is not sufficient to determine the exact number of replicates per case, the nucleotide sequence of the PCR products will be determined.
Measured: Day 1
The length of CAG repeats on exon 1 of AR gene and the relation to sexual function of the participants.
DNA analysis is required for the CAG repeat testing procedure. The DNA will be isolated from venous white blood cells and from endometrial cells. The high-molecular-weight DNA will then be analyzed by PCR amplification protocols, the exon 1 of the androgen receptor gene will be located and the number of CAG repeats will be recorded. If PCR is not sufficient to determine the exact number of replicates per case, the nucleotide sequence of the PCR products will be determined.
The finding will be correlated with the answers of the participants in FSFI scale (Female Sexual Functioning Index )
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Apr 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Androgen Receptor AbnormalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nicosia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dionysis Vaidakis, University of Nicosia
- Investigators
- Maria Chryssi, MSh, Principal investigator, Anticancer oncological hospital of Athens "St Savvas'Dionysios Vaidakis, MD,PhD., Study director, Department of Life & Health Sciences, University of NicosiaAdonis Ioannides, MD,PhD., Study chair, Department of Life & Health Sciences, University of Nicosia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157373
- Sponsor's protocol ID
- DV001
- Acronym
- AREC
- Status last verified
- Dec 2021
- First submitted
- 8 May 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28041951Sanderson 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.
PubMed 27920066Maybin 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.
PubMed 26253932Zitzmann 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.
PubMed 12641825Qin 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.
PubMed 28640128Mao 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.
PubMed 26316780Student 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.
PubMed 31712062Rosenfield 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.
PubMed 27459230Polat 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.
PubMed 32166698Baculescu 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.
PubMed 23599814Zhang 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.
PubMed 23628801
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Androgen Receptor Polymorphism on Endometrial Cancer Development, Progression, and Outcome
- ClinicalTrials.gov ID
- NCT05157373
- Acronym / sponsor ID
- AREC / DV001
- Conditions
- Androgen Receptor Abnormal, Endometrial Disorder
- Keywords
- Androgen Receptor, CAG, Receptor polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of NicosiaUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 15 Dec 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.
Endometrial tissue is a hormonal-dependent tissue in both pre- and postmenopausal period. The endometrial cells are expressing receptors for all sex hormones, mainly for estrogen, progesterone and androgens. The proper response of the endometrial cells on hormones is crucial for a well-balanced fluctuation of endometrial tissue. If, for any reason, these responses are altered, this may lead to benign or malignant lesions.
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
The role of CAG repeats on the AR is well established in degenerative neurological diseases in prostate and breast cancer, but the corresponding role in endometrial benign or malignant lesions is not well studied. It seems that there is a gap in the international literature since the results of the published studies are conflicting. A meta-analysis of 51 studies published by Qin et al. in 2017, suggested that the carriers of short polymorphic CAG repeats might increase the risk of prostate cancer, and could be used as a potential detecting marker. Another meta-analysis of 17 studies concluded that the longest CAG repeats increase the risk of breast cancer. Both those cancers are testosterone dependent and the higher the testosterone serum levels, the greater the cancer risk. Among women, the highest testosterone serum levels are observed in polycystic ovarian syndrome (PCOS) patients. A study published in 2020 concluded that the risk of PCOS is associated with the inheritance of ARs with shorter CAG repeats.Even though a meta-analysis of 11 studies demonstrate no evident association between the CAG length in AR gene and PCOS risk, the CAG length appears to be positively associated with higher testosterone levels. However, larger scale case-control studies are needed to validate the results. The rationale of the present study is to contribute to the literature by correlating the number of CAG repeats on AR with specific endometrial benign or malignant lesions. This may result in a better understanding of the nature of endometrial lesions and the development of specific clinical interventions.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Endometrial sampling and Peripheral blood collection, Behavioral: FSFI ScalePatients with any type of endometrial cancer |
| Group 2 | – | Diagnostic Test: Endometrial sampling and Peripheral blood collection, Behavioral: FSFI ScalePatients with hyperplastic endometrial lesion (all type of endometrial hyperplasia and endometrial polyps). In this group will be included the breast cancer survivors under tamoxifen. |
| Control group | – | Diagnostic Test: Endometrial sampling and Peripheral blood collection, Behavioral: FSFI ScaleA random sample of women without any endometrial pathology. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted at 2 investigative sites in Greece and Cyprus. Recruitment will stop when approximately 150 patients are enrolled. The study will be conducted at UNIC and will include patients from Anticancer Oncological Hospital of Athens ''Saint Savvas Hospital'' and from the researchers' private practices (control group and patients with benign endometrial lesions). All patients meeting the inclusion criteria below will be identified. Up to 150 selected cases from among eligible patients will be enrolled in the study protocol.
Key inclusion criteria (6 listed)
- Women with histologically diagnosed primary endometrial cancer. All stages of endometrial cancer patients can be included in this group.
- Women with the following endometrial lesion:
- Women with histologically proven normal endometrium
Key exclusion criteria (3 listed)
- Women with metastatic cancer in endometrium
- Women with triple negative breast cancer
- Women unable to consent
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 sampling and Peripheral blood collectionThe 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. | Diagnostic test | Control group, Group 1, Group 2 |
| FSFI ScaleThe 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). | Behavioural | Control group, Group 1, Group 2 |
Primary outcome
The length of CAG repeats on exon 1 of AR gene and the relation to endometrial cancer vs control group
Time frame: Day 1
DNA analysis is required for the CAG repeat testing procedure. The DNA will be isolated from venous white blood cells and from endometrial cells. The high-molecular-weight DNA will then be analysed by polymerase chain reaction (PCR) amplification protocols, the exon 1 of the androgen receptor gene will be located and the number of CAG repeats will be recorded. If PCR is not sufficient to determine the exact number of replicates per case, the nucleotide sequence of the PCR products will be determined.
The length of CAG repeats on exon 1 of AR gene and the relation to benign lesions of the endometrium vs control group
Time frame: Day 1
DNA analysis is required for the CAG repeat testing procedure. The DNA will be isolated from venous white blood cells and from endometrial cells. The high-molecular-weight DNA will then be analyzed by PCR amplification protocols, the exon 1 of the androgen receptor gene will be located and the number of CAG repeats will be recorded. If PCR is not sufficient to determine the exact number of replicates per case, the nucleotide sequence of the PCR products will be determined.
The length of CAG repeats on exon 1 of AR gene as a predictive factor for endometrial lesions
Time frame: Day 1
DNA analysis is required for the CAG repeat testing procedure. The DNA will be isolated from venous white blood cells and from endometrial cells. The high-molecular-weight DNA will then be analyzed by PCR amplification protocols, the exon 1 of the androgen receptor gene will be located and the number of CAG repeats will be recorded. If PCR is not sufficient to determine the exact number of replicates per case, the nucleotide sequence of the PCR products will be determined.
3 secondary outcomes
The length of CAG repeats on exon 1 of AR gene and the relation to endometrial cancer stage at diagnosis among group 1 patients
Time frame: Day 1
The length of CAG repeats on exon 1 of AR gene and the relation to endometrial cancer type among group 1 patients
Time frame: Day 1
The length of CAG repeats on exon 1 of AR gene and the relation to sexual function of the participants.
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Results publication: PubMed 28041951Chuffa 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.
- Results publication: PubMed 27920066Sanderson 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.
- Results publication: PubMed 26253932Maybin 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.
- Results publication: PubMed 12641825Zitzmann 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.
- Results publication: PubMed 28640128Qin 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.
- Results publication: PubMed 26316780Mao 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.
- Results publication: PubMed 31712062Student 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.
- Results publication: PubMed 27459230Rosenfield 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.
- Results publication: PubMed 32166698Polat 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.
- Results publication: PubMed 23599814Baculescu 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.
- Results publication: PubMed 23628801Zhang 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.
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.
Maria Chryssi, MSh principal investigator
Anticancer oncological hospital of Athens "St Savvas'
Dionysios Vaidakis, MD,PhD. study director
Department of Life & Health Sciences, University of Nicosia
Adonis Ioannides, MD,PhD. study chair
Department of Life & Health Sciences, University of Nicosia
Questions about this trial
What is this clinical trial studying?
An observational study of Androgen Receptor Abnormal and Endometrial Disorder, run by University of Nicosia.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dionysios Vaidakis, MD,PhD. (00306976355332, Vaidakis.d@unic.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of CAG repeats on exon 1 of AR gene and the relation to endometrial cancer vs control group (time frame: Day 1). 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 NCT05157373, which also lists 11 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 15 Dec 2021.