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临床试验/NCT06355336
NCT06355336招募中不适用

Patient Reported Data on Prostate Cancer Diagnosis, Management, and Outcome: Real World Prostate Cancer Registry

Cincinnati Cancer Advisors1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
To determine practice patterns for prostate cancer in the region.

研究概览

简要总结

Prostate cancer is the most common cancer diagnosed in men in the USA with 268,490 cases diagnosed in 2022 constituting 27% of male cancers and 34,500 deaths (11%) occurred in same year.1 Prostate cancer is a very heterogeneous disease that has different presentations, molecular and pathological features, stages, and disease biology. The treatment options are dependent on the disease stage, its features, and the patient's condition and preferences. The disease outcome also varies significantly due to the previous heterogeneity of the features in addition to other social determinants of health.

Therefore, it is critical to obtain real-world data that reflects the actual patterns of prostate cancer presentation, work up, management, and outcome. Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome.

详细描述

Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome.

Primary Objectives: Describing the patterns of prostate cancer presentation, management, and outcome in the studied population Identify any impact of the compiled variables on treatment selection, work up and outcome.

Secondary Objectives: Identify any gaps and variations in the delivery of care, challenges and needs to optimize management of the disease and improve patient's outcome.

Improve awareness and facilitate enrollment into clinical trials and research studies.

Data will be collected directly from patients. This data will be collected over 10 years with three years of enrollment and seven years of follow-up. Patients provide e-consent and then get login credentials to complete the e-forms which can be edited and updated by the patient. 6 monthly reminders will be sent to the patients to complete 6 monthly follow-ups

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • All patients with pathologically confirmed primary prostate cancer
  • Diagnosis since January 1st, 2023
  • Acceptance to sign the consent form
  • 18 years old or older
  • Resident of Ohio, Kentucky or Indiana

排除标准

  • Having diagnosis of other cancer except squamous cell cancer of the skin
  • Refusal to sign a consent form.

结局指标

主要结局

To determine practice patterns for prostate cancer in the region.

时间窗: 10 years

Descriptive analysis of the disease risk groups, disease stages, and type of treatments provided to the patients (radiation, surgery, hormonal therapy).

次要结局

  • Prevalence of long term complications of prostate cancer treatment.(10 years)
  • To determine progression free survival and overall survival of patients.(10 years)

研究者

发起方
Cincinnati Cancer Advisors
申办方类型
Network
责任方
Sponsor

研究点 (1)

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