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Phase I Human Analytics (HALO) Study

H

HALO Diagnostics

Status

Enrolling

Conditions

Traumatic Brain Injury
Cardiovascular Diseases
Cancer
Dementia

Treatments

Other: no interventions will be performed (observational)

Study type

Observational

Funder types

Industry
Other

Identifiers

NCT05423860
HALO Dx 001
WIRB Pr. No.: 20213955 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

Male

Ages

45 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

2,000 participants in 5 patient groups

dementia
Description:
Patients with a diagnosis of dementia
Treatment:
Other: no interventions will be performed (observational)
Prostate cancer
Description:
patients with a diagnosis of prostate cancer
Treatment:
Other: no interventions will be performed (observational)
breast cancer
Description:
Patients with a diagnosis of breast cancer
Treatment:
Other: no interventions will be performed (observational)
Normal
Description:
Patients without a diagnosis
Treatment:
Other: no interventions will be performed (observational)
tramatic brain injury
Description:
patients with a diagnosis of traumatic brain injury
Treatment:
Other: no interventions will be performed (observational)

Trial contacts and locations

1

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Central trial contact

Erik W Peterson; Christopher R Hancock, MD,MBA

Data sourced from clinicaltrials.gov

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