This is a Human Analytics Longitudinal Observational (HALO) Study. A Phase I Study to Analyze All Available Biomarkers and Determinants of Health to Increase Diagnostic Accuracy While Reducing the Time to Diagnosis of Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Prostate cancer Gleason score
研究概览
简要总结
Discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders. Specifically, our research study endeavors to improve disease and disorder diagnosis to the earliest clinical states, in preclinical states, and to develop ensemble multivariate biomarker risk scores leading to cardiovascular, oncologic, neurologic, and other diseases and disorders.
Additionally, the study aims to:
- Evaluate data analysis techniques to improve diagnostic accuracy and reduce time to diagnosis.
- Evaluate data analysis techniques to improve risk stratification for participants through machine learning algorithms.
- Direct participants to relevant and applicable clinical trials.
详细描述
Electronic medical records contain data that may indicate increased risk for certain diseases and disorders, but clinicians cannot easily discern the subtle patterns required to change their diagnostic and treatment patterns. This study seeks to use machine learning and data analysis techniques to increase diagnostic confidence and reduce time-to-diagnosis related to cardiovascular, oncologic, neurologic, and other diseases and disorders.
The study endeavors to develop ensemble multivariate biomarker risk scores to predict future development of diseases and disorders, improve diagnosis in preclinical states and increase diagnostic accuracy in the earliest clinical states. We also aim to evaluate data analysis techniques to improve diagnostic accuracy and reduce time to diagnosis, improve risk stratification for participants through machine learning algorithms and direct participants to relevant and applicable clinical trials upon physician review, approval and recommendation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Treatment Naïve patients:
- •Male, 45 years of age or older.
- •Diagnosis of prostate adenocarcinoma.
- •Clinical stage T1c or T2a.
- •Gleason score of 7 (3+4 or 4+3) or less.
- •Three or fewer biopsy cores with prostate cancer.
- •PSA density not exceeding 0.
- •One, two, or three tumor suspicious regions identified on multiparametric MRI.
- •Negative radiographic indication of extra-capsular extent.
- •Karnofsky performance status of at least
- •Estimated survival of 5 years or greater, as determined by treating physician.
- •Tolerance for anesthesia/sedation.
- •Ability to give informed consent.
- •At least 6 weeks since any previous prostate biopsy.
- •MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.
- •Salvage candidates will be accepted upon physician referral.
排除标准
- •Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- •Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
- •History of other primary non-skin malignancy within previous three years.
结局指标
主要结局
Prostate cancer Gleason score
时间窗: Up to 5 years after treatment
Measure a patient's prostate cancer Gleason score for patients with a prostate cancer diagnosis and record the measurement again at 3, 6, 9 months and annually for 5 years after treatment. We will use the pathology report submitted by the pathologist. The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score).
Prostate cancer ISUP grade group
时间窗: Up to 5 years after treatment
Measure a patient's prostate cancer ISUP grade group for patients with a prostate cancer diagnosis and record the measurement again at 3, 6, 9 months and annually for 5 years after treatment. We will use the pathology report submitted by the pathologist. The International Society of Urological Pathology (ISUP) guidelines grades the cancer between 1 and 5 depending on the Gleason score. The lower the grade the less likely the cancer is to spread.
Prostate cancer staging parameters
时间窗: Up to 5 years after treatment
TNM stage and metastasis-free survival, documentation of tumor, lymph node and osseous involvement
Prostate cancer specific mortality
时间窗: Up to 5 years
Proportion of men who expire directly due to prostate cancer
次要结局
- Erectile function(Up to 5 years after treatment)
- Emotional well-being(Up to 5 years after treatment)
- Incontinence level(Up to 5 years after treatment)
- Lower urinary tract symptoms (LUTS)(Up to 5 years after treatment)
- PI-RADS category(Up to 5 years after treatment)