Clinical Trial Finder

Phase I Human Analytics (HALO) Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 45 Years - 90 Years
Gender Male
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05423860
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 HALO Diagnostics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Christopher R. Hancock, MDErik W. Peterson, BS
Principal Investigator Affiliation HALO DiagnosticsHALO Diagnostics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry, Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cardiovascular Diseases, Cancer, Dementia, Traumatic Brain Injury
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: dementia

Patients with a diagnosis of dementia

: Prostate cancer

patients with a diagnosis of prostate cancer

: breast cancer

Patients with a diagnosis of breast cancer

: Normal

Patients without a diagnosis

: tramatic brain injury

patients with a diagnosis of traumatic brain injury

Interventions

Other: - no interventions will be performed (observational)

Not applicable. (no interventions will be performed with this observational study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Desert Medical Imaging, Indian Wells 5359426, California 5332921

Status

Recruiting

Address

Desert Medical Imaging

Indian Wells 5359426, California 5332921, 92210

Site Contact

Bernadette M. Greenwood, MSc

[email protected]

760-766-2047

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