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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052048
Recruitment Status : Active, not recruiting
First Posted : August 9, 2019
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Immunis.AI

Study Description
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Brief Summary:
A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.

Condition or disease Intervention/treatment
Prostate Cancer Aggressiveness Diagnostic Test: Subtraction Normalized Expression of Phagocytes Blood Test

Detailed Description:
This study will enroll 600 men who are currently on or are candidates for active surveillance as treatment management for their prostate cancer and are or will be scheduled for a repeat biopsy. A blood sample will be collected and undergo an immunogenomic assay to be compared to their repeat biopsy results. Subjects will then be followed for 10 years with optional serial testing at the time of their active surveillance protocol repeat biopsy. This study's hypothesis is based on the association of immunogenomic signatures from peripheral blood CD2 and CD14 cells with aggressive prostate cancer, and that this signature will identify patients with aggressive prostate cancer from a cohort of patients currently on or are candidates for active surveillance. By comparing the immunogenomic assay to the repeat biopsy information we will identify the assay's ability to predict occult aggressive cancer that would indicate the patient is no longer appropriate for continued active surveillance.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1130 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Men with prostate cancer who are on or are candidates for Active surveillance.
Criteria

Inclusion Criteria:

  • Men between 40-80 with at least a 10-year life expectancy who based on previous prostate biopsy results are either candidates for, or are currently on active surveillance for prostate cancer.

    • Enrollment may be before or after any confirmatory testing.
    • All active surveillance protocols are accepted (Submission of written protocol required with enrollment)
    • No PSA limits
    • Patient agrees to have next surveillance biopsy (specify date or within 3 months)

Exclusion Criteria:

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Michigan
Comprehensive Urology
Royal Oak, Michigan, United States, 48197
Sponsors and Collaborators
Immunis.AI
More Information
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Publications:
Boutros PC, Fraser M, Harding NJ, de Borja R, Trudel D, Lalonde E, Meng A, Hennings-Yeomans PH, McPherson A, Sabelnykova VY, Zia A, Fox NS, Livingstone J, Shiah YJ, Wang J, Beck TA, Have CL, Chong T, Sam M, Johns J, Timms L, Buchner N, Wong A, Watson JD, Simmons TT, P'ng C, Zafarana G, Nguyen F, Luo X, Chu KC, Prokopec SD, Sykes J, Dal Pra A, Berlin A, Brown A, Chan-Seng-Yue MA, Yousif F, Denroche RE, Chong LC, Chen GM, Jung E, Fung C, Starmans MH, Chen H, Govind SK, Hawley J, D'Costa A, Pintilie M, Waggott D, Hach F, Lambin P, Muthuswamy LB, Cooper C, Eeles R, Neal D, Tetu B, Sahinalp C, Stein LD, Fleshner N, Shah SP, Collins CC, Hudson TJ, McPherson JD, van der Kwast T, Bristow RG. Spatial genomic heterogeneity within localized, multifocal prostate cancer. Nat Genet. 2015 Jul;47(7):736-45. doi: 10.1038/ng.3315. Epub 2015 May 25.

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Responsible Party: Immunis.AI
ClinicalTrials.gov Identifier: NCT04052048    
Other Study ID Numbers: ONC-AS-2019
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Aggression
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases
Behavioral Symptoms