Mitigating Risk of COVID-19 for Clinical Management of Genitourinary Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15,240
- 试验地点
- 1
- 主要终点
- Proportion of patients with a new diagnosis of GU
研究概览
简要总结
The purpose of this research study is to identify patients with GU disease with active or past COVID-19 infection.
Participants will be asked to:
- Complete an Online COVID-19 Questionnaire.
- Disclose if the patient has or had Genitourinary cancer or benign urologic condition
- Provide urine specimen for research
- Provide 4 tablespoons of blood for testing blood for research.
- Provide permission to access medical records, such as patient lab results, medical history, imaging reports, etc.
详细描述
COVID-19 has a higher incidence in males compared to females and cancer patients have a higher risk of contracting COVID-19, and developing complications, and deteriorate more rapidly. COVID19 pandemic poses significant challenges in clinical decision-making, which has impacted management of GU patients. In order to mitigate the risk associated with COVID19 pandemic while also providing the best clinical care for patients a screening approach is essential. Clinicians taking care of cancer patients will be expected not only to understand impact of COVID19 but also incorporate a triage tool to decide which patients need immediate treatment. This prospective study presented in this IRB is about establishing a screening tool for GU patients with pre-existing cancer or with benign urological disease (e.g. BPH, kidney stone, bladder infection, urinary tract infections etc) and for those who are dealing with decisions for biopsy, active surveillance, surgery, radiation, hormonal and chemotherapy.
The study team is expecting to enroll 15240 subjects under this study.
Procedures involved in the study:
- Consenting patients for the study.
- Screening/Baseline REDCap survey to determine their COVID-19 symptoms.
- Blood sample collection: This will be obtained for research studies including immune monitoring assays
- Urine sample collection for bio-marker analysis.
- Data collection from medical records, such as:
- Clinical diagnoses, including date of confirmation of SARS-CoV-2 infection
- Any pertinent medical history, including concomitant medications, and comorbidities that pre- date enrollment in the study, or that occur during enrollment in the study
- Laboratory values from time of blood procurement
- All imaging (X-ray, MRI, CAT, PAT, PSMA, Ultrasound, and Pathology etc.) performed from time of initial diagnosis until death, and any needed imaging that pre- date enrollment that may serve as a comparative to pre/post treatment imaging.
- Collection time of samples in relation to study treatment
- Demographic data
- REDCap questionnaire, COVID-19 symptoms and severity of the symptoms
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be men and women 40 years of age or older
- •Subjects at risk or with GU cancer (Prostate, Bladder, Kidney)
- •Subjects with benign GU disorders ( BPH, UTI, Bladder infection and kidney stone)
- •Subjects must have a GU disease that requires clinic visit as determined by physician or healthcare provider following a telehealth appointment
- •Willing and able to provide blood and urine samples
- •Willing and able to complete a questionnaire to determine the COVID-19 symptoms.
- •Willing and able to sign informed consent form
排除标准
- •Men and women below 40 years of age
- •Subjects do not have a GU disease
结局指标
主要结局
Proportion of patients with a new diagnosis of GU
时间窗: Day 1
Proportion of patients with a new diagnosis of GU cancer and with active or past infection with SARS-Co-V-2
次要结局
- Proportion of GU cancer patients, with active disease or in remission(Day 1)
- Proportion of patients with the benign urologic condition(Day 1)
研究者
Ashutosh Kumar Tewari
Professor and System Chair, Urology
Icahn School of Medicine at Mount Sinai