Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Hormones

Prolactin Release-Inhibiting Factors

Androgen Antagonists

Prostate cancer patients or survivors who have a treatment history that includes androgen deprivation therapy. This includes 1) orchiectomy (surgical castration), 2) luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or Gonadotrophin-releasing hormone (GnRH) agonists), 3) LHRH antagonist, 4) CYP17 inhibitor, or 5) anti-androgen.

Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy.

Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease

Non-invasive assessment of left ventricle structure and function

Transthoracic Echocardiography

Continuously monitored for 5-30 minutes via finger photoplethysmography

Arterial blood pressure

Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer

Submaximal Exercise

Carl J Ade, PhD

The aim of this project is to determine whether androgen deprivation therapy (ADT) decreases left ventricular function in prostate cancer patients. If found successful, this may lead to improved cardiovascular health via treatment and/or lifestyle interventions in prostate cancer populations.

Prostate Cancer is the second most common cancer among American men. Approximately 1 in 7 men will be diagnosed with prostate cancer during his lifetime. In prostate cancer patients alone, hypotestosteronemia, caused by prostate cancer treatment is associated with visceral adiposity, insulin resistance, metabolic syndrome, decreased high-density lipoprotein, increased low-density lipoprotein, increased triglycerides, loss of muscle mass, erectile disfunction, and a loss of microvascular endothelial function. Recently, several population-based studies have reported an association between androgen deprivation therapy and an increased risk of cardiovascular events, that include myocardial infarction and cardiovascular mortality. Given this link and the growing evidence that androgen-deprivation therapy adversely affects traditional risk factors, it is essential to better understand the role this type of treatment has on cardiac structure and function. As such, the manifestation of cardiovascular toxicities with prostate cancer treatment will initially be subclinical (left ventricular function changes in asymptomatic individuals) compared to clinical (including coronary symptoms or heart failure) and may develop subacutely (during treatment) or chronically.

Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

Effect of Androgen Deprivation Therapy on Left Ventricular Function in Prostate Cancer Patients and Survivors

measure of left ventricular systolic function

measure of left ventricular systolic and diastolic function

measure of cardiac function at rest and during submaximal exercise

Kansas State University

Assistant Professor

Blood and Lymph Conditions

Rare Diseases

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

Antineoplastic Agents

Cytarabine

Daunorubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Biospecimen Collection

Undergo bone marrow aspiration and biopsy

Bone Marrow Aspiration

Bone Marrow Biopsy

Multigated Acquisition Scan

Revumenib

Site Public Contact

Kiran Naqvi

Olatoyosi M. Odenike

Alice S. Mims

Alice S Mims

This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL/KMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and safety of revumenib (SNDX-5613) combined with 7 + 3 induction in newly diagnosed, untreated, NPM1-mutated/FLT3-ITD wild type and NPM1-mutated/FLT3-TKD wild type or MLL(KMT2A)-rearranged, acute myeloid leukemia (AML) patients \>= 18-75 years old who are candidates for intensive induction therapy.

II. To determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and safety of SNDX-5613 combined with one cycle of consolidation with high dose cytarabine in newly diagnosed AML patients in complete response/complete response with incomplete count recovery (CR/Cri) after intensive induction therapy with 7+3 for NPM1-mutated/FLT3-ITD wild type and NPM1-mutated/FLT3-TKD wild type or MLL (KMT2A)-rearranged AML patients \>= 18-75 years old who are candidates for intensive therapy.

SECONDARY OBJECTIVES:

I. Evaluate the pharmacokinetics of SNDX-5613 with this combination regimen and characterize clinically relevant drug-drug interactions with antifungal agents.

II. To determine the number of patients with CR/CRi out of the total number of patients treated at each dose level of this regimen.

EXPLORATORY OBJECTIVES:

I. Explore potential biomarker indicators of response and resistance in AML samples.

II. To determine the measurable residual disease negative (MRD) response (CR/Cri) and its relation to CR/Cri status out of the total number of patients treated at each dose level of this regimen.

III. Determine number of patients that undergo hematopoietic stem cell transplant (HSCT) out of the total number of patients treated at each dose level of this regimen.

IV. Assess changes in OATP1B and CYP3A plasma biomarkers during treatment with SNDX-5613 with or without antifungal agents.

V. Determine duration of response.

OUTLINE: This is a phase Ib, dose-escalation study of revumenib followed by a dose-expansion study.

INDUCTION: Patients receive revumenib orally (PO) every 12 hours (Q12h) on days 2-28, daunorubicin intravenously (IV) over 15 to 30 minutes on days 1-3, and cytarabine by continuous IV infusion (CIV) on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response to Induction treatment continue to Consolidation treatment. Patients with persistent disease continue to Re-Induction treatment. Patients also undergo a transthoracic echocardiogram (ECHO) or multigated acquisition scan (MUGA) during screening, bone marrow aspiration and biopsy during screening and at the end of Induction, and collection of blood during screening, on days 2, 3, 15, and at the end of Induction.

RE-INDUCTION: Patients receive revumenib PO Q12h on days 2-28, daunorubicin IV over 15 to 30 minutes on days 1-2, and cytarabine CIV on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response to Re-Induction treatment continue to Consolidation. Patients also undergo a transthoracic ECHO or MUGA on day 1 and bone marrow aspiration and biopsy at the end of Re-Induction.

CONSOLIDATION: Patients receive revumenib PO Q12h on days 2-28 and cytarabine CIV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy at the end of Consolidation, and collection of blood on days 2, 3, 15, and at the end of Consolidation.

After completion of study treatment, patients are followed for 30 days or until death, whichever occurs first.

Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene

A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged Disease.

"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."

Will be determined for each patient using 2017 European LeukemiaNet criteria. The number of patients achieving response out of the total number of patients treated at a dose level will be described. Swimmer plots will be utilized to visually display how response improves/changes over time.

MRD negative status is defined as the following for each genomic subgroup: 1) NPM1mutated/FLT3 ITD and FLT3 TKD wildtype: negative NPM1 by polymerase chain reaction testing on bone marrow after cycle 1 of consolidation (or after induction if unable to receive consolidation) or 2) MLL (KMT2A) rearrangement: negative multi-parameter flow cytometry (flow cutoff 10-3) after induction chemotherapy. The number of patients with MRD negative status and the relationship to clinical response will be described at each time point of interest. Swimmer plots will be utilized to visually display how MRD status improves/changes over time.

Median survival will be estimated with 95% confidence interval using Kaplan-Meier method. Swimmer plots will be utilized to visually display how response improves/changes over time.

Median survival will be estimated with 95% confidence interval using Kaplan-Meier method. Swimmer plots will be utilized to capture milestone events including relapse of disease and death for each patient within a given dose level.

Will be described. Swimmer plots will be utilized to capture receipt of HSCT for each patient within a given dose level.

Assess changes in OATP1B and CYP3A plasma biomarkers during treatment with SNDX-5613 with or without antifungal agents.

MTD of induction will be determined based on isotonic regression. Specifically, the MTD is selected as the dose for which the isotonic estimate of the toxicity rate is closest to the targeted dose-limiting toxicity (DLT) (i.e., 25%) via Bayesian Optimal Interval ("BOIN") software (MD Anderson). For all patients who receive at least one dose of any of the study drug(s), adverse events will be documented and summarized by type, grade, severity, and attribution using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. In addition, the number of treatment cycles received and reasons for going off treatment will be summarized to assess treatment tolerability.

MTD of induction will be determined based on isotonic regression. Specifically, the MTD is selected as the dose for which the isotonic estimate of the toxicity rate is closest to the targeted DLT (i.e., 25%) via "BOIN" software (MD Anderson). For all patients who receive at least one dose of any of the study drug(s), adverse events will be documented and summarized by type, grade, severity, and attribution using the CTCAE v5.0 criteria. In addition, the number of treatment cycles received and reasons for going off treatment will be summarized to assess treatment tolerability.

For all patients who receive at least one dose of any of the study drug(s), adverse events will be documented and summarized by type, grade, severity, and attribution using the CTCAE v5.0 criteria. In addition, the number of treatment cycles received and reasons for going off treatment will be summarized to assess treatment tolerability.

The PK sampling is designed to enable estimation of individual PK parameters of SNDX-5613 using standard noncompartmental methods. The primary analysis will compare SNDX-5613 exposure (area under the curve from zero to infinity \[AUCinf\]) on day 2 (before strong antifungal agent administration starting on Day 4 after completion of anthracycline) and steady-state exposure (area under plasma concentration-time curve over dosing interval \[AUCtau\]) on day 15 (after administration of antifungal agent).

Will be calculated by the the number of patients achieving CR/CRi response out of the total number of patients treated on both the dose-escalation and expansion portions with 95% exact binomial confidence interveral.

National Cancer Institute (NCI)

Nervous System Diseases

Heart and Blood Diseases

Digestive System Diseases

Stroke

Urinary Bladder Neoplasms

Pneumoperitoneum

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Natriuretic Agents

Natriuretic Peptide, Brain

Jie Chen, MS

To optimize the perioperative management of patients undergoing laparoscopic radical cystectomy(LPC) for bladder cancer through observation of perioperative changes of Brain Natriuretic Peptide(BNP), stroke volume variation(SVV), central venous pressure(CVP) and the use of transthoracic echocardiography(TTE).

Long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer influence perioperative circulatory function, resulting in a series of pathophysiological changes. BNP is of high sensitivity and specificity in the evaluation of cardiac function. SVV and CVP are dynamic and static indices to predict fluid responsiveness. TTE is a good indicator of volume and cardiac function.Thus, we conducted the trial to assess the perioperative circulatory function in patients undergoing LPC. We hypothesized that long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer would increase perioperative blood volume and influence cardiac function.

Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer

Preliminary Study on the Changes of Perioperative Circulatory Function in Patients Undergoing Laparoscopic Radical Cystectomy for Bladder Cancer

To observe the change of BNP perioperatively.

To observe the change of CVP perioperatively.

To observe the change of SVV perioperatively.

To observe the change of End-diastolic volume(EDV) perioperatively

RenJi Hospital

Principal Investigator, clinical attending in anesthesia department

Symptoms and General Pathology

Disease Progression

Leiomyosarcoma

Neoplasms, Connective and Soft Tissue

Sarcoma

Soft Tissue Sarcoma

Temozolomide

Olaparib

Trabectedin

Poly(ADP-ribose) Polymerase Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients receive temozolomide PO QD on days 1-7 of each cycle and olaparib PO BID on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo collection of blood samples throughout the trial.

Patients receive trabectedin IV continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo TTE or MUGA on study and as clinically indicated, as well as collection of blood samples throughout the trial.

Bone Scan

Computed Tomography

Magnetic Resonance Imaging

Pazopanib

Brian Van Tine

This phase II/III trial compares the effect of the combination treatment with olaparib and temozolomide to trabectedin or pazopanib (two of the most common chemotherapy drugs used as usual approach) in patients with uterine leiomyosarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) after initial chemotherapy has stopped working. The usual approach is defined as care most people get for advanced uterine leiomyosarcoma. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. The combination of olaparib and temozolomide may work better than the usual treatment in shrinking or stabilizing advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.

PRIMARY OBJECTIVES:

I. To compare the progression free survival (PFS) of olaparib plus temozolomide (Arm 1) as compared to investigator's choice (trabectedin or pazopanib hydrochloride \[pazopanib\]) (Arm 2) for the treatment of patients with advanced uterine leiomyosarcoma (uLMS) who have received two or more prior lines of therapy as determined by investigator (local site) assessment. (Phase 2) II. To compare the overall survival (OS) of olaparib plus temozolomide (Arm 1) as compared to investigator's choice (trabectedin or pazopanib) (Arm 2) for the treatment of patients with advanced uLMS who have received two or more prior lines of therapy. (Phase 3)

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of each treatment by determining adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 5 and patient-reported toxicity using Patient-Reported Outcome (PRO)-CTCAE version 1 in and across each treatment arm. (Phase 2/3) II. To evaluate the objective response rate (ORR), duration of response (DOR) and disease control rate (DCR) in and across each treatment arm as determined by investigator assessment. (Phase 2/3)

EXPLORATORY OBJECTIVE:

I. To collect results of tumor genomic testing previously conducted as part of clinical care (when available) and (a) to determine the proportion of patients with a genomic alteration in a homologous recombination (HR) pathway gene and (b) to evaluate for any relationship between the presence of such an alteration and clinical benefit from olaparib and temozolomide. (Phase 2/3)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive temozolomide orally (PO) once daily (QD) on days 1-7 of each cycle and olaparib PO twice daily (BID) on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and/or bone scans throughout the trial. Patients also undergo collection of blood samples throughout the trial.

ARM 2: Patients receive trabectedin intravenously (IV) continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo transthoracic echocardiography (TTE) or multi-gated acquisition scan (MUGA) on study and as clinically indicated, as well as collection of blood samples throughout the trial.

After completion of study treatment, patients without disease progression are followed every 6 weeks until disease progression. After disease progression, patients are followed every 3 months for the first 2 years, then every 6 months thereafter until 5 years post-randomization or death, whichever comes first.

Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working

A Randomized Phase 2/3 Study of Olaparib Plus Temozolomide Versus Investigator's Choice for the Treatment of Patients With Advanced Uterine Leiomyosarcoma After Progression on Prior Chemotherapy

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Will collect results of next generation sequencing that is known to the treating investigator and was previously performed as part of the patient's clinical care, for all patients registered to the study. Will evaluate for genomic alterations in HR pathway genes. A genomic alteration is defined as a homozygous deletion or deleterious (loss-of-function) mutation in any of the pre-defined HR pathway genes.

Will evaluate whether patients with an HR pathway alteration experience increased clinical benefit from olaparib and temozolomide as compared patients who lack such an alteration, as determined by objective response rate, progression-free survival and overall survival. Response rates will be compared using the Fisher's exact test, and time to event endpoints summarized using the Kaplan-Meier curves and the log-rank test.

Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. PFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well.

Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well.

Will be estimated by dividing the number of evaluable patients that achieve a confirmed response (partial response \[PR\] or better) by the total number of evaluable patients. This estimate will be calculated by arm and will also include a 95% confidence interval using the properties of the binomial distribution, and compared between the arms using a chi-square test.

This analysis is restricted to those patients that achieved a confirmed response (PR or better). Patients that go off of study treatment prior to progression will have their DOR time censored at that time.

Will be estimated using the number of patients that achieve complete response, partial response, or stable disease at the 6 week assessment divided by all evaluable patients. This estimate will be calculated by arm and will also include a 95% confidence interval using the properties of the binomial distribution, and compared between the arms using a chi-square test.

Adverse events will be recorded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for each patient. Frequency tables and summary statistics will be used and with the appropriate methods of evaluating categorical and continuous data. In addition, patient reported safety and tolerability will be assessed using Patient-Reported Outcomes (PRO)-CTCAE for a prespecified group of expected toxicities. PRO-CTCAE assessments will occur prior to registration and on day 1 of every cycle during treatment. Collection of PRO-CTCAE will be discontinued after cycle 11.

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Immune System Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 1

Necrosis

Systolic Murmurs

Heart Murmurs

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Autoimmune Diseases

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

We will include in this group patients with a diagnosis of T1DM, determined according to the World Health Organization criteria, who need insulin treatment and whose diabetes duration is more than 1 year. Patients will not have additional chronic diseases and will not have any other medical treatments other than insulin.

Patients will not have additional chronic diseases or other medical treatments. They will often be selected on a voluntary basis from patients who apply to pediatric cardiology with symptoms such as murmur or chest pain.

All echocardiographic studies will be performed by one physician (Merve Maze AYDEMIR) using a commercially available echocardiographic system (P4-2 probe, DC-60, Mindray, Shenzhen, China) in the back-to-top or left lateral decubitus position. All images will be digitally stored from three cardiac cycles as standard apical four-chamber and parasternal short-axis views.

transthoracic echocardiography

MERVE MA AYDEMİR

Tahir Çağdaş

Özge Doğan

Veysel Tahiroğlu

Cem Mete

Hasan Karageçili

The goal of this clinical trial is to learn about the effect of type 1 diabetes mellitus on cardiac functions and evaluate the correlation of the dysfunction with the tumor necrosis factor-α (TNF-α) an inflammation-related factor. The study population will be the patients with the diagnosis of type 1 diabetes mellitus and the healthy children es the control group. The main question\[s\] it aims to answer are:

* Is diabetes affecting the systolic and diastolic cardiac functions
* Is diabetes affecting the left and the right ventricles equally?
* Does diabetes status, as assessed by HbA1c, have an impact on the occurrence of cardiac dysfunction?
* Is TNF-α can be a marker for early diagnosis of cardiac dysfunction? Diabetic patients will be examined by both a pediatric endocrinologist and a pediatric cardiologist. Transthoracic echocardiography will be performed and TNF-α will be evaluated for both the diabetic patients and the healthy children.

Type 1 Diabetes Mellitus (T1DM) patients are at risk of developing cardiac dysfunction, a serious complication. Conventional echocardiography and tissue Doppler echocardiography are the most commonly used methods to evaluate cardiac functions. This study aims to prospectively assess the cardiac functions of pediatric patients diagnosed with T1DM. After routine pediatric endocrinology assessments, including anthropometric measurements, monitoring of blood glucose charts, and inquiring about complications related to diabetes, patients will be referred for pediatric cardiology evaluation. Standard pediatric cardiac examination, electrocardiographic evaluation, and echocardiography, including conventional transthoracic echocardiography and tissue Doppler echocardiography, will be performed.

Patients with a T1DM diagnosis typically provide blood samples for standard tests (HgA1c, blood glucose, routine biochemistry, etc.) following each pediatric endocrinology visit. In this study, an additional blood sample will be taken during blood collection to measure tumor necrosis factor-alpha (TNF-α) levels. Previous studies have shown elevated TNF-α levels in T1DM patients. This study aims to investigate its potential impact on cardiac function. Similarly, an age- and gender-matched control group of healthy children without T1DM will be established. This control group will also undergo echocardiographic evaluation, and TNF-α levels in their blood will be measured. Subsequently, statistical analysis will be conducted.

Through these assessments, this study aims to determine whether there is a deterioration in systolic and diastolic heart functions in the pediatric T1DM patient group compared to the control group and to evaluate the effect of TNF-α levels on these results.

Blood samples will be taken for the analyses of TNF-a.

Tumor Necrosis Factor-alpha Levels and Cardiac Functions in Type 1 Diabetes Mellitus

Evaluation of Tumor Necrosis Factor-alpha Levels and Cardiac Functions in Pediatric Patients Diagnosed With Type 1 Diabetes Mellitus

We will include Type 1 DM patients diagnosed for over a year. After routine pediatric endocrinology assessments, they'll visit the pediatric cardiology clinic. By echocardiography, ejection fraction (EF) and fractional shortening (FS) will be measured in percentages. For these calculations, Left ventricular end-diastolic dimension, Interventricular septum, and LV posterior wall thickness in systole and diastole will be measured in mm. The expected normal value for EF is \>%55 and FS \> %30.

To assess diastolic dysfunction by echocardiography, the mitral diastolic flow tracings will be imaged in pulsed Doppler with sample volume sited at the tips of the mitral leaflets. Peak velocities of early (E) and late (A) filling (m/s) will be derived from atrioventricular valve inflow velocity profiles. The early to late peak velocities (E/A) ratio will be calculated. In addition, by tissue Doppler imaging echocardiography, myocardial wall motion velocity will be recorded by activating the pulsed-wave (PW) tissue Doppler function on the same machine. LV septal and lateral mitral annulus measures: early (Em) and late (Am) (m/s) diastolic myocardial velocities, isovolumic contraction time , isovolumic relaxation time and ejection time (ms) will be measured. The myocardial performance index will be calculated as (IVCT + IVRT)/ET.

The tricuspid diastolic flow tracings will be imaged in pulsed Doppler to assess diastolic dysfunction by echocardiography. Peak velocities of early (E) and late (A) filling (m/s) will be derived from atrioventricular valve inflow velocity profiles. The early to late peak velocities (E/A) ratio will be calculated. In addition, by tissue. For lateral tricuspid annulus, early (Em) and late (Am) (m/s) diastolic myocardial velocities, isovolumic contraction time, isovolumic relaxation time, and ejection time (ms) will be measured by Doppler imaging echocardiography. The myocardial performance index will be calculated as (IVCT + IVRT)/ET. Tricuspid annular plane systolic excursion (TAPSE) (mm) will be assessed for systolic function.

This study will include T1DM patients diagnosed for over a year who have undergone routine pediatric endocrinology evaluations. We'll collect extra blood samples to measure TNF-α levels (pg/mL). We will evaluate whether blood TNF-α levels are higher in patients who develop systolic and/or diastolic dysfunction compared to patients who do not develop dysfunction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer	NCT03275181	Prostate Cancer	Transthoracic E... Arterial blood ... Submaximal Exer...	21 Years - 80 Years	Kansas State University
Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene	NCT05886049	Acute Myeloid L... Acute Myeloid L...	Biospecimen Col... Bone Marrow Asp... Bone Marrow Bio... Cytarabine Daunorubicin Multigated Acqu... Revumenib Transthoracic E...	18 Years - 75 Years	National Cancer Institute (NCI)
Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene	NCT05886049	Acute Myeloid L... Acute Myeloid L...	Biospecimen Col... Bone Marrow Asp... Bone Marrow Bio... Cytarabine Daunorubicin Multigated Acqu... Revumenib Transthoracic E...	18 Years - 75 Years	National Cancer Institute (NCI)
Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer	NCT03892031	Circulatory Fun... Laparoscopic Ra...		18 Years - 90 Years	RenJi Hospital
Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working	NCT05432791	Locally Advance... Metastatic Uter... Stage III Uteri... Stage IV Uterin... Unresectable Ut...	Biospecimen Col... Bone Scan Computed Tomogr... Magnetic Resona... Multigated Acqu... Olaparib Pazopanib Temozolomide Trabectedin Transthoracic E...	18 Years -	National Cancer Institute (NCI)
Tumor Necrosis Factor-alpha Levels and Cardiac Functions in Type 1 Diabetes Mellitus	NCT06129448	Diabetes Mellit... Systolic Dysfun... Diastolic Dysfu...	transthoracic e...	1 Year - 18 Years	Sirnak State Hospital
Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer	NCT03275181	Prostate Cancer	Transthoracic E... Arterial blood ... Submaximal Exer...	21 Years - 80 Years	Kansas State University

Spots Global Cancer Trial Database for transthoracic echocardiography