Phase I Human Analytics (HALO) Study

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)