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Cancer Diagnostic Test
ExoDx Prostate (IntelliScore) for Prostate Cancer
N/A
Waitlist Available
Led By Ronald F Tutrone, MD
Research Sponsored by Exosome Diagnostics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing the usefulness of a urine test in predicting aggressive prostate cancer.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate performance of the ExoDx Prostate(IntelliScore)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cohort AExperimental Treatment1 Intervention
Patients randomized to Cohort A will receive ExoDx Prostate (IntelliScore) test results along with a post-ExoDx Prostate (IntelliScore) test result questionnaire to evaluate impact of test results in the biopsy decision process, utility, ease of understanding and work-flow implementation.
Group II: Cohort BActive Control1 Intervention
Patients randomized to Cohort B will proceed with conventional standard of care.
Find a Location
Who is running the clinical trial?
Chesapeake Urology Research AssociatesOTHER
2 Previous Clinical Trials
116 Total Patients Enrolled
1 Trials studying Prostate Cancer
42 Patients Enrolled for Prostate Cancer
Exosome Diagnostics, Inc.Lead Sponsor
9 Previous Clinical Trials
9,682 Total Patients Enrolled
4 Trials studying Prostate Cancer
8,190 Patients Enrolled for Prostate Cancer
CareFirst BlueCross BlueShieldUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a previous prostate biopsy.You have signs of a urinary tract infection or prostatitis when you join the study.You have had prostate cancer in the past.You have had both kidney and bladder tumors at the same time in the past.There is a strong possibility that you have prostate cancer based on clinical signs and symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts still underway for this undertaking?
"According to the records on clinicaltrials.gov, this research project is not currently enrolling any participants; it was initially posted in July 2017 and last revised in May 2022. Unfortunately, no vacancies are available for this trial yet but 1321 other trials remain open for recruitment at present."
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