Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Wounds and Injuries

Nutritional and Metabolic Diseases

Prostatic Neoplasms

Fractures, Stress

Vitamin D Deficiency

Fractures, Bone

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Vitamins

Vitamin D

Cholecalciferol

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.

Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year

cholecalciferol

RNA-seq analysis will be used to (a) identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men and (b) compare Allostatic Load results to determine stress response and (c) identify changes in the molecular signature in relation to vitamin D levels

Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq

Pathology results of the prostate biopsies will be analyzed for changes in the (a) Gleason Score (b) the number of positive cores (0 to 12) and (c) the highest percentage of positive core involvement (0 to 100%).

Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation

Allostatic Load measurements to determine body stress compared at baseline and after one year of vitamin D3 supplementation. Also compared with RNA-seq results to determine stress response.

Allostatic Load Measurements at baseline and after one year vitamin D3 supplementation

Chanita Hughes-Halbert, PhD

Veterans between the ages of 50-75, who are having a prostate biopsy, will be recruited for their permission to collect an extra biopsy core for RNA-sequencing. If the participants' treatment decision is Active Surveillance, they will be enrolled into the intervention phase of the study. They will receive supplementation with Vitamin D3 (4,000 IU) daily with repeat (surveillance) prostate biopsy one year later. At that time an extra prostate sample core will be collected for RNA-sequencing to determine changes over time. Measurements for allostatic load (body stress/inflammatory markers) will also be collected at the time of enrollment and at the repeat prostate biopsy visit.

This is an open-label pilot study. The goal is to investigate the transcription and biological pathways in prostate cancer that are especially relevant to prostate cancer disparities between African American and Caucasian men. Also, to determine any significant differences in the molecular signature that exist in African American and Caucasian men in relation to their Vitamin D levels.

Recruitment will be at the Urology Clinic at the Ralph H. Johnson VA Medical Center in Charleston, SC. Men who are scheduled for a Standard of Care prostate biopsy will be consented for their permission to collect an extra prostate tissue core for RNA-sequencing.

After the pathology report is discussed by their Urologist, and the treatment decision is Active Surveillance, the participant is enrolled into the Intervention Phase. At that time, baseline allostatic load measurements (Blood pressure, pulse, waist/hip ratio, height, and weight for BMI) and bloodwork: (lipid panel, HgbA1c, albumin and creatinine, IL-6, CRP, and DHEA-s (inflammatory markers) plus a Vitamin D level, will be collected. Vitamin D3 soft gels (4,000 IU) daily (six months' supply) will be dispensed. A Social Determinants survey will also be dispensed for subject completion.

At the Urology Standard of Care six-month follow-up appointment, the vitamin D serum level will be collected and the next six months' supply of vitamin D3 will be dispensed.

At the Urology Standard of Care follow-up (repeat at 1 year) surveillance prostate biopsy, an extra prostate tissue core will be collected for RNA-sequencing. The allostatic load measurements and bloodwork will also be obtained.

Individuals having a prostate biopsy are eligible for recruitment.

Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans

Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans

RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.

The first reported finding in the pathology report is the Gleason Score. When the prostate sample is examined under the microscope, the Pathologist determines which type of cell is the most common and which type is the second most common. Each of these cell types is given a score from 1 to 5. Higher numbers mean more abnormal, aggressive cancer cells. Because the two most common types of cancer cells are identified, the Gleason Score is a combination of these two cell types. For example, the first most common cell type is a 3 and the second is reported as a 4, then the Gleason Score is 3+4, or 7.

Changes to the baseline and repeat prostate biopsy Gleason Score will be analyzed.

During a routine prostate biopsy, 12 core samples are collected: 2 samples from the top right, front and back, 2 from the top left, front and back; 2 from the middle right and 2 from the middle left; 2 from the bottom right and 2 from the bottom left. When the 12 cores are examined under the microscope, the Pathologist identifies which cores contain cancer cells (or are positive for cancer).

Therefore, the pathology report will identify the number of positive cores between 0 to 12.

Changes to the baseline and repeat prostate biopsy positive core will be analyzed.

When the Pathologist examines the 12 core samples from the prostate biopsy, the percentage of cancer cells that are in each core is also identified. This can be from 0 to 100 percent involvement.

To facilitate the evaluation of the 12 percentages reported for the 12 cores in the pathology report, the Urology standard is to prioritize and assess the highest percentage of core involvement.

Changes to the baseline and repeat biopsy highest percentage core involvement will be analyzed.

RNA-seq analyses of prostate tissue plus allostatic load measurements to determine stress response

Ralph H. Johnson VA Medical Center

National Institute on Minority Health and Health Disparities (NIMHD)

Medical University of South Carolina

Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Despite increased access to early detection and the availability of more effective therapeutic strategies, African American women continue to experience excess rates of morbidity and mortality from breast cancer. An emerging hypothesis about breast cancer disparities is that social conditions and physiological responses to social stressors influence biological processes that are important to the initiation and progression of disease. This hypothesis is based on data from animal studies which have shown that rats that are exposed to social stressors such as isolation are likely to develop mammary tumors that are histologically and etiologically similar to those that develop among African American women. The HPA axis plays a central role in regulating the physiological stress response; dysregulation of the HPA has been suggested as a mechanism through which social and biological factors contribute to racial disparities in breast cancer outcomes. Many African Americans experience stressful life events and circumstances, including economic, discriminatory, and other stressors. These social factors may contribute to an increased risk of advanced stage disease, but not all African American women who are exposed to adverse social factors develop advanced stage disease and those who have a limited number of psychosocial stressors can develop advanced stage breast cancer, regardless of early detection. This may be because stress reactivity, or one's physiological and psychological responses to a stressor, is highly individualized and dependent on psychological and social determinants as well as genetic factors. But, these biological and psychosocial pathways have not been examined among women at increased risk for disparities. Therefore, this study will characterize stress reactivity and emotional regulation among African American breast cancer survivors and measure the association between these responses and decisions about cancer control and treatment compliance. As part of providing empirical data on biological and psychological pathways that contribute to breast cancer disparities, the investigator's study will identify novel intervention targets that can be used to improve self-management in a population that is at risk for limited cancer control.

Dysregulation of the HPA has been suggested as a mechanism through which social and biological factors contribute to racial disparities in breast cancer outcomes.The HPA axis plays a central role in regulating the physiological stress response;a prolonged and elevated glucocorticoid (GC) response following a social stressor predicts tumor growth rates and the development of mammary cancer in rats that histologically and etiologically resembles human disease.Many African Americans experience stressful life events and circumstances, including economic, discriminatory, and other stressors. These psychosocial factors may contribute to an increased risk of advanced stage breast cancer among African American women, but not all African American women who are exposed to adverse psychosocial and social stressors develop advanced stage breast cancer and African American women who have a limited number of stressors also develop advanced stage breast cancer, regardless of early detection. This may be because stress reactivity, or one's physiological and psychological responses to a stressor, is highly individualized and dependent on psychological and social determinants. However, empirical data are not available on stress reactivity among African American breast cancer survivors and how these reactions vary among women based on their exposure to chronic stressors and psychological characteristics. Empirical data are also lacking on the association between stress reactivity and cancer control behaviors among African American breast cancer survivors even though prior studies have shown that these women are less likely than whites to engage in health behaviors that are important to cancer control and research is now being conducted to understand how stress affects these behaviors.This research is testing the hypothesis that stress: (1) promotes temporal discounting; (2) has an adverse effect on self-efficacy, and (3) reduces executive functioning (e.g., goal setting, planning). However, stress reactivity, and the association between these responses and cancer control behaviors (e.g., diet, physical activity, and treatment compliance), have not been examined among African American breast cancer survivors. Prior studies have shown that African Americans have a dysregulated stress response as a result of persistent exposure to chronic and acute and stressors; this may alter stress responses and lead to high levels of allostatic load. In order to develop effective behavioral interventions for African American breast cancer survivors, an important first step is to verify that the mechanisms (e.g., temporal discounting, self-efficacy) involved in health behaviors for cancer control (e.g., diet, physical activity, treatment compliance) are associated with stress reactivity among these women. Therefore this study will characterize stress reactivity among African American breast cancer survivors and validate the association between these responses and targeted mechanisms of behavior change.

Blood samples, urine samples, and saliva samples

Due to the nature of this study, only women who were born biologically as female will be eligible to participate in this study. Men who develop breast cancer have a different pathophysiology than women, and therefore, will not be included in this sample.

Stress Reactivity Among African American Breast Cancer Survivors

The Science of Behavior Change in African American Breast Cancer Survivors

Conduct an A Tier Social Stress Test (TSST)with patients to induce a stress response. Cortisol is being examined as a stress biomarker and will be measured at baseline, at multiple timepoints (n=3) during the TSST, and immediately after the TSST to assess changes in cortisol levels.

Collect vital assessments that include heart rate and systolic and diastolic blood pressure at baseline, during the course of the Trier Social Stress Test (TSST), and immediately after the TSST in order to examine changes in vitals as it relates to stress responses during the TSST.

Characterize the nature and distribution of stress reactivity among African American breast cancer survivors based on socioeconomic, clinical, and social stressors. Socioeconomic status will be collected via self-report utilizing household income and education items from the Behavioral Risk Factor Surveillance System (BRFSS) tool. Financial strain will be evaluated using the Comprehensive Score for financial Toxicity (COST) tool. Social stress will be assessed by levels of social isolation using the loneliness scale. Clinical variables relating to disease stage will be extracted from the patient's electronic medical record.

A blood sample will determine circulating levels of neutrophils, lymphocytes, and monocytes to determine glucocorticoid sensitivity.

The Kirby Delay Discounting Task conducted immediately (10 minutes) or longer (20 minutes) following exposure to the Trier Social Stress Test to examine temporal discounting.

Self-reported diet behaviors will be associated with levels of stress reactivity 1-month following stress induction.

Self-reported physical activity behaviors will be associated with levels of stress reactivity 1-month following stress induction.

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Behavior, Addictive

Nicotine

Kendra Rowe

Massey CPC Team

Chanita Hughes Halbert, PhD

Trista Beard, EdD

Robert Winn, MD

The purpose of this study is to examine racial differences in smoking behaviors and stress responses between African American and white male smokers.

Cigarette smoking is a leading cause of morbidity and mortality from lung cancer among adults in the US. Stress relief and smoking cessation is the best preventive strategy for reducing lung cancer risk and addressing racial disparities in outcomes. Despite this, racial differences are found among those that make quit attempts. Stress has been found to be related to smoking initiation, maintenance, and relapse. Yet, differences in stress responses have not been examined between African American and white smokers. Therefore, this study will examine racial differences in stress responses and smoking behaviors between African American and white male smokers

Saliva will be conducted for analyzing biomarkers of stress (i.e. cortisol, alpha-amylase), and biomarkers related to smoking (i.e. cotinine)

Urine will be collected to determine the presence of illicit substances as an indicator of exclusion/inclusion into the study.

Patients that provide consent will have additional saliva and urine collected and stored in a centralized biorepository for future research

Translational Research Center in Lung Cancer Disparities (TRACER) Project 2

Biological Pathways in Stress Reactivity and Nicotine Addiction Among African American and White Smokers

Examine racial differences in acute stress responses using a validated psychological stress challenge called the Trier Social Stress Test (TSST)

Examine racial differences in daily diurnal cortisol slopes to evaluate hypothalamic-pituitary-adrenal-axis dysregulation and acute stress

Patients will be administered a survey using validated measures to examine socioeconomic, structural, and psychosocial stressors that impact daily stress and smoking behaviors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans	NCT04621500	Prostate Cancer Vitamin D Defic... Stress Reaction	cholecalciferol Standard of Car... Standard of Car... Allostatic Load...	50 Years - 75 Years	Medical University of South Carolina
Stress Reactivity Among African American Breast Cancer Survivors	NCT03881085	Breast Cancer F... Stress Reaction		21 Years - 75 Years	Medical University of South Carolina
Translational Research Center in Lung Cancer Disparities (TRACER) Project 2	NCT05490251	Smoking Smoking Behavio... Smoking Cessati... Stress Reaction		18 Years - 75 Years	Virginia Commonwealth University

Spots Global Cancer Trial Database for stress reaction