Active Surveillance SNEP Assay Registry Trial for Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04052048|
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : January 25, 2023
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|Condition or disease||Intervention/treatment|
|Prostate Cancer Aggressiveness||Diagnostic Test: Subtraction Normalized Expression of Phagocytes Blood Test|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||A Multi-center, Prospective Active Surveillance Registry Trial Assessing the Performance of a Non-invasive Immunogenomic Blood Test for Indolent Prostate Cancer Disease Management.|
|Actual Study Start Date :||September 9, 2019|
|Estimated Primary Completion Date :||November 15, 2023|
|Estimated Study Completion Date :||September 30, 2029|
- Diagnostic Test: Subtraction Normalized Expression of Phagocytes Blood Test
Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness
- Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population. [ Time Frame: 1 year ]Collect information from repeat biopsy including any increase in gleason grade, increase in number of cores positive, and increase in % cross sectional surface area involved by tumor from the repeat biopsy.
- Validate immunogenomic assay's ability to serve as an ongoing, non-invasive tool to monitor patient risk for disease progression as detected by repeat biopsy. [ Time Frame: 10 years ]On an annual basis, collect follow-up frequency data for each patient including optional repeat blood testing, repeat biopsy data, disease management decisions, and disease progression.
Biospecimen Retention: Samples With DNA
Three tubes of blood:
Two 8ml CPT One 4ml SST
Prostate Biopsy slides
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||40 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Men between 40-80 of age with at least a 10-year life expectancy
- All active surveillance protocols are accepted
- No PSA limits
- Patient is currently on active surveillance with only ONE previous low grade prostate biopsy.
- Patient must already be scheduled for their 1st annual biopsy under their active surveillance protocol within 90 days of enrollment date.
• Patient is recently diagnosed with low grade prostate cancer but has decided against active surveillance and is scheduled for radical prostatectomy within 90 days of enrollment date.
Men on watchful waiting i.e. those with less than 10-year life expectancy with no intent for curative therapy
- Men with symptoms or rising PSA who have not been proven to have cancer by tissue biopsy i.e. men with only negative prostate biopsies.
- Patients with a history of a different cancer (except basal cell carcinoma)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052048
|Contact: Jessica DeHartfirstname.lastname@example.org|
|United States, Michigan|
|Royal Oak, Michigan, United States, 48197|
|Contact: Bridget Makhlouf 248-336-1080 email@example.com|
|Contact: Patrick Keating 248-336-1080 firstname.lastname@example.org|
|Principal Investigator: Howard Korman, MD|
|Other Study ID Numbers:||
|First Posted:||August 9, 2019 Key Record Dates|
|Last Update Posted:||January 25, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|
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