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NCT Number: NCT05423860

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.

Recruiting

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Key information

Conditions

Cardiovascular Diseases Brain Diseases Brain Injuries Brain Injuries, Traumatic Cancer Central Nervous System Diseases Craniocerebral Trauma Dementia Mental Disorders Neoplasms Nervous System Diseases Neurocognitive Disorders Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

45 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

Desert Medical Imaging

Indian Wells, California, 92210, United States

Location status: Recruiting

Location contact

Bernadette M. Greenwood, BSc

SUB_INVESTIGATOR

Bernadette M. Greenwood, MSc

CONTACT

760-766-2047

Chris R Hancock, MD

PRINCIPAL_INVESTIGATOR

ERIK PETERSON, BS

CONTACT

[email protected]

4147455773

Erik W Peterson, BS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no interventions will be performed (observational)

Other

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

Primary outcomes

  1. Prostate cancer Gleason score

    Time frame: Up to 5 years after treatment

    Measure a patient's prostate cancer Gleason score for patients with a prostate cancer diagnosis and record the measurement again at 3, 6, 9 months and annually for 5 years after treatment. We will use the pathology report submitted by the pathologist. The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score).

  2. Prostate cancer ISUP grade group

    Time frame: Up to 5 years after treatment

    Measure a patient's prostate cancer ISUP grade group for patients with a prostate cancer diagnosis and record the measurement again at 3, 6, 9 months and annually for 5 years after treatment. We will use the pathology report submitted by the pathologist. The International Society of Urological Pathology (ISUP) guidelines grades the cancer between 1 and 5 depending on the Gleason score. The lower the grade the less likely the cancer is to spread.

  3. Prostate cancer staging parameters

    Time frame: Up to 5 years after treatment

    TNM stage and metastasis-free survival, documentation of tumor, lymph node and osseous involvement

  4. Prostate cancer specific mortality

    Time frame: Up to 5 years

    Proportion of men who expire directly due to prostate cancer

Secondary outcomes

  1. Lower urinary tract symptoms (LUTS)

    Time frame: Up to 5 years after treatment

    Measure patient's prostate symptom score for patients with a prostate cancer diagnosis and repeat the survey at 3, 6, 9 months and annually for 5 years after treatment. We will use the International Prostate Symptom Score (I-PSS) survey. The International Prostate Symptom Score (IPSS) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH).

  2. Erectile function

    Time frame: Up to 5 years after treatment

    Measure a patient's sexual health score for patients with a prostate cancer diagnosis and repeat the survey at 3, 6, 9 months and annually for 5 years after treatment. We will use the Sexual Health Inventory for Men survey. The Sexual Health Inventory for Men (SHIM) is a widely used scale for screening and diagnosis of erectile dysfunction (ED) and severity of ED in clinical practice and research.

  3. Emotional well-being

    Time frame: Up to 5 years after treatment

    Measure a patient's level of distress for patients with a prostate cancer diagnosis and repeat the survey at 3, 6, 9 months and annually for 5 years after treatment. We will use the NCCN-DT survey. The NCCN Distress Thermometer and Problem List is a well-known screening tool among cancer care providers. The survey is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment.

  4. Incontinence level

    Time frame: Up to 5 years after treatment

    Measure a patient's incontinence for patients with a prostate cancer diagnosis and repeat the survey at 3, 6, 9 months and annually for 5 years after treatment. We will use the ICIQ-UI Short Form survey. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world.

  5. PI-RADS category

    Time frame: Up to 5 years after treatment

    Measure a patient's PI-RADS category for patients with a prostate cancer diagnosis and record measurement again at 3, 6, 9 months and annually for 5 years after treatment. We will use the radiology report submitted by the radiologist. Radiologists use the Prostate Imaging Reporting and Data System (PI-RADS) to report how likely it is that a suspicious area is a clinically significant cancer. In the PI-RADS scale, each lesion is assigned a score from 1 to 5 indicating the likelihood of clinically significant cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher R Hancock, MD,MBA

CONTACT

[email protected]

760-776-8989

Erik W Peterson

CONTACT

[email protected]

414-745-5773

Sponsors and collaborators

Lead sponsor

HALO Diagnostics

Industry

Collaborators

  • HALO Affiliate Sites

Registry information

Official study 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.

Acronym: HALO

Important dates

Study start
2022
Primary completion
2027
Study completion
2037
First posted
Jun 21, 2022
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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