RECRUITING

Phase I Human Analytics (HALO) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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.

Quick Facts

Study Start:2022-03-16
Study Completion:2037-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05423860

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.

Ages Eligible for Study:45 Years to 90 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male, 45 years of age or older.
  2. * Diagnosis of prostate adenocarcinoma.
  3. * Clinical stage T1c or T2a.
  4. * Gleason score of 7 (3+4 or 4+3) or less.
  5. * Three or fewer biopsy cores with prostate cancer.
  6. * PSA density not exceeding 0.375.
  7. * One, two, or three tumor suspicious regions identified on multiparametric MRI.
  8. * Negative radiographic indication of extra-capsular extent.
  9. * Karnofsky performance status of at least 70.
  10. * Estimated survival of 5 years or greater, as determined by treating physician.
  11. * Tolerance for anesthesia/sedation.
  12. * Ability to give informed consent.
  13. * At least 6 weeks since any previous prostate biopsy.
  14. * 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.
  1. * Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
  2. * Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
  3. * History of other primary non-skin malignancy within previous three years.
  4. * Diabetes
  5. * Smoker

Contacts and Locations

Study Contact

Christopher R Hancock, MD,MBA
CONTACT
760-776-8989
chris.hancock@halodx.com
Erik W Peterson
CONTACT
414-745-5773
ERIK.PETERSON@HALODX.COM

Principal Investigator

Christopher R. Hancock, MD
PRINCIPAL_INVESTIGATOR
HALO Diagnostics
Erik W. Peterson, BS
STUDY_DIRECTOR
HALO Diagnostics

Study Locations (Sites)

Desert Medical Imaging
Indian Wells, California, 92210
United States

Collaborators and Investigators

Sponsor: HALO Diagnostics

  • Christopher R. Hancock, MD, PRINCIPAL_INVESTIGATOR, HALO Diagnostics
  • Erik W. Peterson, BS, STUDY_DIRECTOR, HALO Diagnostics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-16
Study Completion Date2037-03

Study Record Updates

Study Start Date2022-03-16
Study Completion Date2037-03

Terms related to this study

Keywords Provided by Researchers

  • brain
  • breast
  • prostate
  • cardiac
  • cancer

Additional Relevant MeSH Terms

  • Cardiovascular Diseases
  • Cancer
  • Dementia
  • Traumatic Brain Injury