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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,000
Not applicable. (no interventions will be performed with this observational study
Desert Medical Imaging
Indian Wells, California, United States
RECRUITINGProstate cancer Gleason score
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).
Time frame: Up to 5 years after treatment
Prostate cancer ISUP grade group
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.
Time frame: Up to 5 years after treatment
Prostate cancer staging parameters
TNM stage and metastasis-free survival, documentation of tumor, lymph node and osseous involvement
Time frame: Up to 5 years after treatment
Prostate cancer specific mortality
Proportion of men who expire directly due to prostate cancer
Time frame: Up to 5 years
Lower urinary tract symptoms (LUTS)
Measure patient's prostate symptom score for patients with a prostate cancer diagnosis and repeat the survey at 3, 6, 9 months and annually for 5 years after treatment. We will use the International Prostate Symptom Score (I-PSS) survey. The International Prostate Symptom Score (IPSS) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH).
Time frame: Up to 5 years after treatment
Erectile function
Measure a patient's sexual health score for patients with a prostate cancer diagnosis and repeat the survey at 3, 6, 9 months and annually for 5 years after treatment. We will use the Sexual Health Inventory for Men survey. The Sexual Health Inventory for Men (SHIM) is a widely used scale for screening and diagnosis of erectile dysfunction (ED) and severity of ED in clinical practice and research.
Time frame: Up to 5 years after treatment
Emotional well-being
Measure a patient's level of distress for patients with a prostate cancer diagnosis and repeat the survey at 3, 6, 9 months and annually for 5 years after treatment. We will use the NCCN-DT survey. The NCCN Distress Thermometer and Problem List is a well-known screening tool among cancer care providers. The survey is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment.
Time frame: Up to 5 years after treatment
Incontinence level
Measure a patient's incontinence for patients with a prostate cancer diagnosis and repeat the survey at 3, 6, 9 months and annually for 5 years after treatment. We will use the ICIQ-UI Short Form survey. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world.
Time frame: Up to 5 years after treatment
PI-RADS category
Measure a patient's PI-RADS category for patients with a prostate cancer diagnosis and record measurement again at 3, 6, 9 months and annually for 5 years after treatment. We will use the radiology report submitted by the radiologist. Radiologists use the Prostate Imaging Reporting and Data System (PI-RADS) to report how likely it is that a suspicious area is a clinically significant cancer. In the PI-RADS scale, each lesion is assigned a score from 1 to 5 indicating the likelihood of clinically significant cancer.
Time frame: Up to 5 years after treatment
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