Clinical trial · Observational
Active Surveillance SNEP Assay Registry Trial for Prostate Cancer
A Multi-center, Prospective Active Surveillance Registry Trial Assessing the Performance of a Non-invasive Immunogenomic Blood Test for Indolent Prostate Cancer Disease Management.
NCT04052048CI-TRIAL-00107201recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Aggressiveness | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Subtraction Normalized Expression of Phagocytes Blood Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population.
- timeFrame
- 1 year
- description
- 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 outcomes (1)
- measure
- 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.
- timeFrame
- 10 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria * Men between 40-80 of age with at least a 10-year life expectancy * All active surveillance protocols are accepted * No PSA limits Category 1: * 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. Category 2: • 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. 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)
References
Publications (11)
- BACKGROUNDPalmer C, Diehn M, Alizadeh AA, Brown PO. Cell-type specific gene expression profiles of leukocytes in human peripheral blood. BMC Genomics. 2006 May 16;7:115. doi: 10.1186/1471-2164-7-115. PMID 16704732
- BACKGROUNDSchmidl C, Renner K, Peter K, Eder R, Lassmann T, Balwierz PJ, Itoh M, Nagao-Sato S, Kawaji H, Carninci P, Suzuki H, Hayashizaki Y, Andreesen R, Hume DA, Hoffmann P, Forrest AR, Kreutz MP, Edinger M, Rehli M; FANTOM consortium. Transcription and enhancer profiling in human monocyte subsets. Blood. 2014 Apr 24;123(17):e90-9. doi: 10.1182/blood-2013-02-484188. Epub 2014 Mar 26. PMID 24671955
- BACKGROUNDHashimoto S, Nagai S, Sese J, Suzuki T, Obata A, Sato T, Toyoda N, Dong HY, Kurachi M, Nagahata T, Shizuno K, Morishita S, Matsushima K. Gene expression profile in human leukocytes. Blood. 2003 May 1;101(9):3509-13. doi: 10.1182/blood-2002-06-1866. Epub 2003 Jan 9. PMID 12522010
- BACKGROUNDDale DC, Boxer L, Liles WC. The phagocytes: neutrophils and monocytes. Blood. 2008 Aug 15;112(4):935-45. doi: 10.1182/blood-2007-12-077917. PMID 18684880
- BACKGROUNDGutknecht MF, Bouton AH. Functional significance of mononuclear phagocyte populations generated through adult hematopoiesis. J Leukoc Biol. 2014 Dec;96(6):969-80. doi: 10.1189/jlb.1RI0414-195R. Epub 2014 Sep 15. PMID 25225678
- BACKGROUNDChow A, Brown BD, Merad M. Studying the mononuclear phagocyte system in the molecular age. Nat Rev Immunol. 2011 Oct 25;11(11):788-98. doi: 10.1038/nri3087. PMID 22025056
- BACKGROUNDEpstein JI. An update of the Gleason grading system. J Urol. 2010 Feb;183(2):433-40. doi: 10.1016/j.juro.2009.10.046. Epub 2009 Dec 14. PMID 20006878
- Grignon DJ. Prostate cancer reporting and staging: needle biopsy and radical prostatectomy specimens. Mod Pathol. 2018 Jan;31(S1):S96-109. doi: 10.1038/modpathol.2017.167.