Phase I Human Analytics (HALO) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Cardiovascular Diseases, Cancer, Dementia, Traumatic Brain Injury

Intervention / Treatment
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* Other: no interventions will be performed (observational)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 0.375. One, two, or three tumor suspicious regions identified on multiparametric MRI. Negative radiographic indication of extra-capsular extent. Karnofsky performance status of at least 70. 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. Exclusion Criteria: 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. Diabetes Smoker

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dementia<br>Patients with a diagnosis of dementia | Other: no interventions will be performed (observational)<br>* Not applicable. (no interventions will be performed with this observational study<br>|
| Prostate cancer<br>patients with a diagnosis of prostate cancer | Other: no interventions will be performed (observational)<br>* Not applicable. (no interventions will be performed with this observational study<br>|
| breast cancer<br>Patients with a diagnosis of breast cancer | Other: no interventions will be performed (observational)<br>* Not applicable. (no interventions will be performed with this observational study<br>|
| Normal<br>Patients without a diagnosis | Other: no interventions will be performed (observational)<br>* Not applicable. (no interventions will be performed with this observational study<br>|
| tramatic brain injury<br>patients with a diagnosis of traumatic brain injury | Other: no interventions will be performed (observational)<br>* Not applicable. (no interventions will be performed with this observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate 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). | 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. | Up to 5 years after treatment | 
| Prostate cancer staging parameters | TNM stage and metastasis-free survival, documentation of tumor, lymph node and osseous involvement | Up to 5 years after treatment | 
| Prostate cancer specific mortality | Proportion of men who expire directly due to prostate cancer | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 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. | Up to 5 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain, breast, prostate, cardiac, cancer