| NCT ID | NCT05423860 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HALO Diagnostics |
| Condition | Cardiovascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2022-03-16 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2022-03-16 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Christopher R. Hancock, MD
PRINCIPAL INVESTIGATOR
HALO Diagnostics
Frequently Asked Questions
Who can join the NCT05423860 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 90 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05423860 currently recruiting?
Yes, NCT05423860 is actively recruiting participants. Contact the research team at chris.hancock@halodx.com for enrollment information.
Where is the NCT05423860 trial being conducted?
This trial is being conducted at Indian Wells, United States.
Who is sponsoring the NCT05423860 clinical trial?
NCT05423860 is sponsored by HALO Diagnostics. The principal investigator is Christopher R. Hancock, MD at HALO Diagnostics. The trial plans to enroll 2,000 participants.