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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05370300
Other study ID # SNAPS Breast Cancer
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2025
Est. completion date December 31, 2027

Study information

Verified date March 2024
Source Immunis.AI
Contact Amanda Nash
Phone 855-855-6484
Email amanda.nash@duke.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Differential immunogenomic signatures from peripheral blood CD14 (phagocytic) and CD2 (non-phagocytic) cells have been associated with multiple cancers and disease states. In particular several large clinical studies at Immunis.AI have demonstrated robust immunogenomic signatures in early-stage prostate cancer. Immunis.AI therefore hypothesizes that a peripheral blood immunogenomic signature will identify patients with various stages of breast cancer from healthy negative controls.


Description:

Efficient next generation RNA sequencing platforms have allowed for whole genome expression profiling of individual populations of immune cells as a novel means of searching for patterns of gene expression to aid in the identification of meaningful signals unique to various disease states. Single cell sequencing techniques have provided additional information useful in deconvolution strategies applied to model development on purified populations of immune cells. Recent interest in peripheral leukocyte subset gene expression profiles suggests that diagnostic information for many disorders may be contained therein. Mononuclear phagocytic cells including the various CD14+ subsets have been studied extensively in various disease states including some solid tumors. Previous large clinical studies at Immunis.AI have determined that transcriptomic profiles of CD14+ cell populations subtraction normalized from CD2+ cell populations were associated with aggressive disease phenotypes such as prostate cancer. Tumor heterogeneity, multifocality, and oligoclonality have been a significant barrier to development of meaningful tissue based multigene signatures for predicting cancer biologic behavior. The findings at Immunis.AI strongly suggest that analysis of RNA expression data from the body's immune surveillance cells has the potential to summarize the entire heterogeneous tumor. The investigators believe that the CD14/CD2 log ratio can be understood as a subtraction normalization of gene expression which yields superior signal of early-stage cancer.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date December 31, 2027
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients > 18 yrs of age. - Patients diagnosed with stage I-IV breast cancer, who have not begun definitive therapy. - Patients undergoing screening mammograms for breast cancer. Exclusion Criteria: - Patients with a history of a different cancer within the previous 3 years (except non melanoma skin cancer). - Any prior treatment (surgery, chemo, hormonal, radiation, biologics, etc.) for current cancer. - Any biopsy which resulted in the entire tumor tissue being removed. - History of previous breast cancer. - Patients unable to provide informed consent. - Patients with an abnormal screening mammogram. - Patients whose hormone receptor and/or HER2 status are not available.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood test
Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.

Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Immunis.AI Duke University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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, — View Citation

Cher ML, Dhir A, Auffenberg GB, Linsell S, Gao Y, Rosenberg B, Jafri SM, Klotz L, Miller DC, Ghani KR, Bernstein SJ, Montie JE, Lane BR; Michigan Urological Surgery Improvement Collaborative. Appropriateness Criteria for Active Surveillance of Prostate Ca — View Citation

Chow 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. — View Citation

Dale 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. — View Citation

Epstein JI. Update on the Gleason grading system. Ann Pathol. 2011 Nov;31(5 Suppl):S20-6. doi: 10.1016/j.annpat.2011.08.023. Epub 2011 Sep 28. No abstract available. — View Citation

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. — View Citation

Gutknecht 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. — View Citation

Hashimoto 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 2 — View Citation

Palmer 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. — View Citation

Schmidl 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 — View Citation

Van Neste L, Wojno KJ, Henao R, Mane S, Korman H, Hafron J, Kernen K, Tinawi-Aljundi R, Putzi M, Kassis AI, Kantoff PW. Evaluation of an RNAseq-Based Immunogenomic Liquid Biopsy Approach in Early-Stage Prostate Cancer. Cells. 2021 Sep 28;10(10):2567. doi: — View Citation

Womble PR, Montie JE, Ye Z, Linsell SM, Lane BR, Miller DC; Michigan Urological Surgery Improvement Collaborative. Contemporary use of initial active surveillance among men in Michigan with low-risk prostate cancer. Eur Urol. 2015 Jan;67(1):44-50. doi: 10 — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Aim To determine if differential gene expression between peripheral blood phagocytic and non-phagocytic immune cells can distinguish breast cancer patients from cancer-negative controls. 12 months
Secondary Secondary Aim 1 To evaluate minimal residual disease with a potential signature for breast cancer detection following curative therapy to evaluate the degree to which the original signature has changed. 12 months
Secondary Secondary Aim 2 To determine the sample size required to develop and validate a computational immunogenomic model capable of predicting the various types, grades, and stages of breast cancer. 12 months
Secondary Secondary Aim 3 To determine the temporal relation between biopsy procedures and signal strength or dilution. 12 months
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