Endometrial Disorder Clinical Trial
— ARECOfficial title:
The Effect of Androgen Receptor Polymorphism on Endometrial Cancer Development, Progression, and Outcome
NCT number | NCT05157373 |
Other study ID # | DV001 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2022 |
Est. completion date | April 1, 2024 |
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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria 1. Women with histologically diagnosed primary endometrial cancer. All stages of endometrial cancer patients can be included in this group. 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: 1. Women with metastatic cancer in endometrium 2. Women with triple negative breast cancer 3. Women unable to consent |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Nicosia |
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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. — View Citation
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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-analys — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 1 | |
Primary | 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. | Day 1 | |
Primary | 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. | Day 1 | |
Secondary | 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. | Day 1 | |
Secondary | 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. | Day 1 | |
Secondary | 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 ) |
Day 1 |
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