Recruiting

Diagnostic Measures

Sponsor:

HALO Diagnostics

Code:

NCT05423860

Conditions

Cardiovascular Diseases

Cancer

Dementia

Traumatic Brain Injury

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

no interventions will be performed (observational)

Study Details

Brief summary:

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

Study ID

NCT05423860

Start date

Mar 16, 2022

Status verified date

Oct, 2022

Completion date

Mar, 2037

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

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

no interventions will be performed (observational)

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

Primary outcome measure

  • Prostate cancer Gleason score [ Time Frame: Up to 5 years after treatment ]
  • Prostate cancer ISUP grade group [ Time Frame: Up to 5 years after treatment ]
  • Prostate cancer staging parameters [ Time Frame: Up to 5 years after treatment ]
  • Prostate cancer specific mortality [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Christopher R Hancock, MD,MBA

760-776-8989chris.hancock@halodx.com

Erik W Peterson

414-745-5773ERIK.PETERSON@HALODX.COM

Locations

Desert Medical Imaging

Recruiting

Indian Wells, California, United States, 92210

Contacts

Bernadette M. Greenwood, MSc

760-766-2047

ERIK PETERSON, BS

4147455773ERIK.PETERSON@HALODX.COM

Principal Investigator:

Chris R Hancock, MD

More Information

Sponsor

HALO Diagnostics

Last update posted

Oct 14, 2022

Last verified

Oct, 2022

Keywords

  • brain
  • breast
  • prostate
  • cardiac
  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HALO Diagnostics on 2022-10-14.