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| ID | Type | Description | Link |
|---|---|---|---|
| WIRB Pr. No.: 20213955 | Other Identifier | WIRB Copernicus Group (WCG) |
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| Name | Class |
|---|---|
| HALO Affiliate Sites | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dementia | Patients with a diagnosis of dementia |
| |
| Prostate cancer | patients with a diagnosis of prostate cancer |
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| breast cancer | Patients with a diagnosis of breast cancer |
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| Normal | Patients without a diagnosis |
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| tramatic brain injury | patients with a diagnosis of traumatic brain injury |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no interventions will be performed (observational) | Other | Not applicable. (no interventions will be performed with this observational study |
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| 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 |
| 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). |
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Inclusion Criteria:
Treatment Naïve patients:
Salvage candidates will be accepted upon physician referral.
Exclusion Criteria:
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Men with prostate cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher R Hancock, MD,MBA | Contact | 760-776-8989 | chris.hancock@halodx.com | |
| Erik W Peterson | Contact | 414-745-5773 | ERIK.PETERSON@HALODX.COM |
| Name | Affiliation | Role |
|---|---|---|
| Christopher R. Hancock, MD | HALO Diagnostics | Principal Investigator |
| Erik W. Peterson, BS | HALO Diagnostics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Medical Imaging | Recruiting | Indian Wells | California | 92210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28376093 | Background | Weng SF, Reps J, Kai J, Garibaldi JM, Qureshi N. Can machine-learning improve cardiovascular risk prediction using routine clinical data? PLoS One. 2017 Apr 4;12(4):e0174944. doi: 10.1371/journal.pone.0174944. eCollection 2017. | |
| 25288876 | Background | Wang X, Oldani MJ, Zhao X, Huang X, Qian D. A review of cancer risk prediction models with genetic variants. Cancer Inform. 2014 Sep 21;13(Suppl 2):19-28. doi: 10.4137/CIN.S13788. eCollection 2014. |
| Label | URL |
|---|---|
| HALO Diagnostics | View source |
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Publication
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Interval updates may be presented at scientific meetings as available. Interim results may also be published.
Scientists and physicians
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009369 | Neoplasms |
| D003704 | Dementia |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| 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 |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |