SNAPS Breast Cancer Patient Study Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Subtraction Normalized Aggregated Phagocytic Signal in Peripheral Blood of Breast Cancer Patients (SNAPS - Clinical Trial) A NextGen RNASeq Feasibility Study of a Blood-based Model for Early Cancer Detection and Surveillance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05370300
• Other study ID #: SNAPS Breast Cancer
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms

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 all — Click 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