Cardiovascular DiseasesHALONCT05423860
Phase I Human Analytics (HALO) Study
An observational study of Cardiovascular Diseases and Cancer, run by HALO Diagnostics at 1 site in United States.
Trial summary
Discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders. Read more about this study
- Who is it for?
- Ages 45 to 90 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Cancer, Dementia
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2022to Mar 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with prostate cancer
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Desert Medical Imaging
Indian Wells, California, 92210
Bernadette M. Greenwood, MSc, 760-766-2047
ERIK PETERSON, BS, 4147455773, ERIK.PETERSON@HALODX.COM
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases, Cancer, Dementia, Traumatic Brain Injury
- Being tested
- no interventions will be performed (observational)
- Keywords
- brain, breast, prostate, cardiac, cancer
- Medical subject headings
- Cardiovascular Diseases, Neoplasms, Dementia, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventions will be performed (observational)Other
Not applicable. (no interventions will be performed with this observational study
| Study group | Role | What they receive |
|---|---|---|
| dementia | Patients with a diagnosis of dementia Receives: Other: no interventions will be performed (observational) | |
| Prostate cancer | patients with a diagnosis of prostate cancer Receives: Other: no interventions will be performed (observational) | |
| breast cancer | Patients with a diagnosis of breast cancer Receives: Other: no interventions will be performed (observational) | |
| Normal | Patients without a diagnosis Receives: Other: no interventions will be performed (observational) | |
| tramatic brain injury | patients with a diagnosis of traumatic brain injury Receives: Other: no interventions will be performed (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer Gleason score
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).
Measured: Up to 5 years after treatment
Prostate cancer ISUP grade group
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.
Measured: Up to 5 years after treatment
Prostate cancer staging parameters
TNM stage and metastasis-free survival, documentation of tumor, lymph node and osseous involvement
Measured: Up to 5 years after treatment
Prostate cancer specific mortality
Proportion of men who expire directly due to prostate cancer
Measured: Up to 5 years
Secondary outcomes (5)
Lower urinary tract symptoms (LUTS)
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).
Measured: Up to 5 years after treatment
Erectile function
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.
Measured: Up to 5 years after treatment
Emotional well-being
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.
Measured: Up to 5 years after treatment
Incontinence level
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.
Measured: Up to 5 years after treatment
PI-RADS category
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.
Measured: Up to 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start16 Mar 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HALO Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HALO Affiliate Sites
- Responsible party
- Sponsor
- Investigators
- Christopher R. Hancock, MD, Principal investigator, HALO DiagnosticsErik W. Peterson, BS, Study director, HALO Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423860
- Sponsor's protocol ID
- HALO Dx 001
- Other IDs
- WIRB Pr. No.: 20213955
- Acronym
- HALO
- Status last verified
- Oct 2022
- First submitted
- 29 Apr 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Publication
Publications
Weng SF, Reps J, Kai J, Garibaldi JM, Qureshi N. Can machine-learning improve cardiovascular risk prediction using routine clinical data? PLoS One. 2017 Apr 4;12(4):e0174944. doi: 10.1371/journal.pone.0174944. eCollection 2017.
PubMed 28376093Wang X, Oldani MJ, Zhao X, Huang X, Qian D. A review of cancer risk prediction models with genetic variants. Cancer Inform. 2014 Sep 21;13(Suppl 2):19-28. doi: 10.4137/CIN.S13788. eCollection 2014.
PubMed 25288876
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05423860
- Acronym / sponsor ID
- HALO / HALO Dx 001
- Conditions
- Cardiovascular Diseases, Cancer, Dementia, Traumatic Brain Injury
- Keywords
- brain, breast, prostate, cardiac, cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- HALO DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- HALO Affiliate Sites
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2037 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dementia | – | Other: no interventions will be performed (observational)Patients with a diagnosis of dementia |
| Prostate cancer | – | Other: no interventions will be performed (observational)patients with a diagnosis of prostate cancer |
| breast cancer | – | Other: no interventions will be performed (observational)Patients with a diagnosis of breast cancer |
| Normal | – | Other: no interventions will be performed (observational)Patients without a diagnosis |
| tramatic brain injury | – | Other: no interventions will be performed (observational)patients with a diagnosis of traumatic brain injury |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with prostate cancer
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventions will be performed (observational)Not applicable. (no interventions will be performed with this observational study | Other | Normal, Prostate cancer, breast cancer, dementia, tramatic brain injury |
Primary outcome
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).
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.
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
Prostate cancer specific mortality
Time frame: Up to 5 years
Proportion of men who expire directly due to prostate cancer
5 secondary outcomes
Lower urinary tract symptoms (LUTS)
Time frame: Up to 5 years after treatment
Erectile function
Time frame: Up to 5 years after treatment
Emotional well-being
Time frame: Up to 5 years after treatment
Incontinence level
Time frame: Up to 5 years after treatment
PI-RADS category
Time frame: Up to 5 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Background: PubMed 28376093Weng SF, Reps J, Kai J, Garibaldi JM, Qureshi N. Can machine-learning improve cardiovascular risk prediction using routine clinical data? PLoS One. 2017 Apr 4;12(4):e0174944. doi: 10.1371/journal.pone.0174944. eCollection 2017.
- Background: PubMed 25288876Wang X, Oldani MJ, Zhao X, Huang X, Qian D. A review of cancer risk prediction models with genetic variants. Cancer Inform. 2014 Sep 21;13(Suppl 2):19-28. doi: 10.4137/CIN.S13788. eCollection 2014.
- HALO DiagnosticsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher R. Hancock, MD principal investigator
HALO Diagnostics
Erik W. Peterson, BS study director
HALO Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cancer, run by HALO Diagnostics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher R Hancock, MD,MBA (760-776-8989, chris.hancock@halodx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate cancer Gleason score (time frame: Up to 5 years after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05423860, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.