Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Disease Progression

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kennedy Disease

All Drugs and Chemicals

Bone Density Conservation Agents

Antineoplastic Agents

Androgens

Tamoxifen

Patients with any type of endometrial cancer

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.

A random sample of women without any endometrial pathology.

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.

Endometrial sampling and Peripheral blood collection

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).

FSFI Scale

Dionysios Vaidakis, MD,PhD.

Maria Chryssi, MSh

Adonis Ioannides, MD,PhD.

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.

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.

The Effect of Androgen Receptor Polymorphism on Endometrial Cancer

The Effect of Androgen Receptor Polymorphism on Endometrial Cancer Development, Progression, and Outcome

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.

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.

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 )

University of Nicosia

Clinical Assistant Professor

Blood and Lymph Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Cytarabine

Decitabine

Mitogens

Aclarubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

decitabine (15 mg/m2 daily, days 1-5); low-dose cytarabine (10 mg/m2 q12 h, days 3-9); rhTPO (15,000 U daily, days 2, 4, 6, 8, and 10-24 or until a platelet count \> 50 × 109/L was observed); aclarubicin (14 mg/m2 daily, days 3-6); and G-CSF (300 μg daily, days 2-9).

rhTPO

Huihan Wang, Doctor

Acute myeloid leukemia (AML) is a disease affecting older adults, although optimal strategies for treating such patients remain unclear. This prospective phase II, openlabel, multicenter study was designed to assess the efficacy and safety of two hematologic growth factors, recombinant human thrombopoietin (rhTPO) and granulocyte colonystimulating factor (G-CSF), in combination with decitabine, cytarabine, and aclarubicin (D-CTAG regimen) to treat older adults with newly diagnosed AML (Identifier: NCT04168138). The above agents were administered as follows: decitabine (15 mg/m2 daily, days 1-5); low-dose cytarabine (10 mg/m2 q12 h, days 3-9); rhTPO (15,000U daily, days 2, 4, 6, 8, 10-24 or until \>50×109/L platelets); aclarubicin (14 mg/m2 daily, days 3-6); and G-CSF (300 μg daily, days 2-9). We concurrently monitored historic controls treated with decitabine followed by cytarabine, aclarubicin, and G-CSF (D-CAG) only. After the first D-CTAG cycle, the overall response rate (ORR) was 84.2% (16/19), including 13 (73.7%) complete remissions (CRs) and three (15.8%) partial remissions. This CR rate surpassed that of the D-CAG treatment (p \< 0.05). Median overall survival (OS) time in the D-CTAG group was 20.2 months (range, 4-31 months), compared with 14 months in the D-CAG group, and 1-year OS was 78%. The proportion of those experiencing grade III-IV thrombocytopenia was significantly lower for D-CTAG (57.9%) than for D-CAG (88.4%; p \< 0.05). Ultimately, the curative effect of adding rhTPO was not inferior to that of D-CAG, and D-CTAG proved safer for elderly patients, especially in terms of hematologic toxicity. A prospective phase III randomized study is warranted to confirm these observations.

Acute myeloid leukemia (AML) is one of the most common hematologic malignancies and affects older adults. The median age at diagnosis is 67 years. As the elderly increasingly account for a greater population percentage, AML is becoming more problematic. During the past 30 years, outcomes have improved for younger patients, whereas the prospects for older adults (\> 60 years) have remained poor. The response rate in older adults given standard induction regimens is \< 50%, and median overall survival (OS) is \< 1 year. Older adults elderly are also inordinately burdened by unfavorable cytogenetic defects, medical comorbidities, and reduced tolerability to intensive chemotherapeutic protocols. These vulnerabilities predispose older adults to poorer outcomes than their younger counterparts, conferring lower response rates and shortened survival times (progression-free and overall survival \[OS\]). Safe and effective treatments for elderly patients with AML are thus urgently needed.

In 2000, Saito et al introduced a regimen of granulocyte colony-stimulating factor (G-CSF) plus low-dose cytarabine (ara-C) and aclarubicin (ACR) for use in this setting (CAG regimen), in an attempt to incorporate a hematologic growth factor in AML induction therapy, rather than relying on supportive care. The addition of decitabine, a demethylation agent, further improved the prognosis, yielding a 10-month median OS. This successful use of G-CSF in an induction regimen for AML confirmed its utility, helping to increase efficacy and reduce side effects in elderly patients.

Thrombopoietin (TPO) is a major factor in regulating megakaryocytic proliferation, maturation, and platelet formation. Recombinant human TPO (rhTPO) has been approved by China's State Food and Drug Administration to treat thrombocytopenia after chemotherapy. TPO and c-MPL receptors are also involved in various physiologic processes, such as mitigating myocardial injury, nerve repair, vascular regeneration, sex hormone secretion, and immune regulation. However, the role of rhTPO in an induction regimen for AML is unreported as yet.

To determine if adding rhTPO to D-CAG (G-CSF) will increase the overall response rate (ORR) while decreasing the side effect of toxic agents, we designed a regimen of rhTPO and G-CSF in combination with decitabine, cytarabine, and aclarubicin (D-CTAG regimen). This trial aimed to determine the safety and efficacy of this D-CTAG regimen as a treatment for older adult patients with newly diagnosed AML.

Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen for Elderly Patients With Acute Myeloid Leukemia: A Phase II Single-Arm Multicenter Study

Huihan Wang

Deputy Chief Physician

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effect of Androgen Receptor Polymorphism on Endometrial Cancer	NCT05157373	Androgen Recept... Endometrial Dis...	Endometrial sam... FSFI Scale	18 Years - 90 Years	University of Nicosia
Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen for Elderly Patients With Acute Myeloid Leukemia: A Phase II Single-Arm Multicenter Study	NCT05258799	Acute Myeloid L...	rhTPO	60 Years -	Shengjing Hospital

Spots Global Cancer Trial Database for cag

Every month we try and update this database with for cag cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cag

Every month we try and update this database with for cag cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cag cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.