Phase I Human Analytics (HALO) Study (HALO)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Cancer; Dementia; Traumatic Brain Injury
• Intervention / Treatment: Other: no interventions will be performed (observational)

Detailed Description

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 (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Christopher R Hancock, MD,MBA; Phone Number: 760-776-8989; Email: chris.hancock@halodx.com
• Study Contact Backup: Name: Erik W Peterson; Phone Number: 414-745-5773; Email: ERIK.PETERSON@HALODX.COM

Study Locations

• United States
  • California
    • Indian Wells, California, United States, 92210
      • Recruiting
      • Desert Medical Imaging
      • Contact: Bernadette M. Greenwood, MSc; Phone Number: 760-766-2047
      • Contact: ERIK PETERSON, BS; Phone Number: 4147455773; Email: ERIK.PETERSON@HALODX.COM
      • Principal Investigator: Chris R Hancock, MD
      • Sub-Investigator: Bernadette M. Greenwood, BSc
      • Sub-Investigator: Erik W Peterson, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with prostate cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dementia; Patients with a diagnosis of dementia	Other: no interventions will be performed (observational); Not applicable. (no interventions will be performed with this observational study
Prostate cancer; patients with a diagnosis of prostate cancer	Other: no interventions will be performed (observational); Not applicable. (no interventions will be performed with this observational study
breast cancer; Patients with a diagnosis of breast cancer	Other: no interventions will be performed (observational); Not applicable. (no interventions will be performed with this observational study
Normal; Patients without a diagnosis	Other: no interventions will be performed (observational); Not applicable. (no interventions will be performed with this observational study
tramatic brain injury; patients with a diagnosis of traumatic brain injury	Other: no interventions will be performed (observational); Not applicable. (no interventions will be performed with this observational study

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HALO Diagnostics
• Collaborators: HALO Affiliate Sites
• Investigators: Principal Investigator: Christopher R. Hancock, MD, HALO Diagnostics; Study Director: Erik W. Peterson, BS, HALO Diagnostics

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• HALO Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Anticipated): March 1, 2027
• Study Completion (Anticipated): March 1, 2037

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: cancer; breast; brain; prostate; cardiac
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cardiovascular Diseases; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: HALO Dx 001; WIRB Pr. No.: 20213955 (Other Identifier: WIRB Copernicus Group (WCG))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publication
• IPD Sharing Time Frame: Interval updates may be presented at scientific meetings as available. Interim results may also be published.
• IPD Sharing Access Criteria: Scientists and physicians

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No