Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05423860
Other study ID # HALO Dx 001
Secondary ID WIRB Pr. No.: 20
Status Recruiting
Phase
First received
Last updated
Start date March 16, 2022
Est. completion date March 2037

Study information

Verified date October 2022
Source HALO Diagnostics
Contact Christopher R Hancock, MD,MBA
Phone 760-776-8989
Email chris.hancock@halodx.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date March 2037
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 90 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Desert Medical Imaging Indian Wells California

Sponsors (2)

Lead Sponsor Collaborator
HALO Diagnostics HALO Affiliate Sites

Country where clinical trial is conducted

United States, 

References & Publications (2)

Wang 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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Up to 5 years after treatment
Primary 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. Up to 5 years after treatment
Primary Prostate cancer staging parameters TNM stage and metastasis-free survival, documentation of tumor, lymph node and osseous involvement Up to 5 years after treatment
Primary Prostate cancer specific mortality Proportion of men who expire directly due to prostate cancer Up to 5 years
Secondary 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). Up to 5 years after treatment
Secondary 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. Up to 5 years after treatment
Secondary 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. Up to 5 years after treatment
Secondary 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. Up to 5 years after treatment
Secondary 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. Up to 5 years after treatment
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases

External Links