Phase I Human Analytics (HALO) Study
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 Start (Actual)
16 March 2022
🗓️ Primary Completion (Estimated)
March 2027
✅ Study Completion (Estimated)
March 2037
👥 Enrollment (Estimated)
2000
🔬 Study Type
OBSERVATIONAL
📊 Phase
N/A
Locations:
📍
Indian Wells, California, United States
Description
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
Ages Eligible for Study:
45 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
No
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
- First Submitted
29 April 2022
- First Submitted that Met QC Criteria
15 June 2022
- First Posted
21 June 2022
Study Record Updates
- Last Update Submitted that Met QC Criteria
12 October 2022
- Last Update Posted
14 October 2022
- Last Verified
October 2022