Phase I Human Analytics (HALO) Study

Description

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.

Conditions

Cardiovascular Diseases, Cancer, Dementia, Traumatic Brain Injury

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Study Overview

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Study Details

Study overview

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.

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.

Phase I Human Analytics (HALO) Study

Condition
Cardiovascular Diseases
Intervention / Treatment

-

Contacts and Locations

Indian Wells

Desert Medical Imaging, Indian Wells, California, United States, 92210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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

45 Years to 90 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

HALO Diagnostics,

Christopher R. Hancock, MD, PRINCIPAL_INVESTIGATOR, HALO Diagnostics

Erik W. Peterson, BS, STUDY_DIRECTOR, HALO Diagnostics

Study Record Dates

2037-03