SNAPS Breast Cancer Patient Study Breast Cancer Patients

NCT05370300 | Not Yet Recruiting

• 1 other identifier: SNAPS Breast Cancer
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Cancer Female

Keywords

Breast Cancer; Immunogenomics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary Aim 1

  12 months

• Secondary Aim 2

  12 months

• Secondary Aim 3

  12 months

Study Arms (2)

Controls: Patients with negative screening MMG

Patients presenting to Duke Radiology for routine screening mammogram will be screened for eligibility as negative controls. Study enrollment for negative controls presumes that patients do not receive their screening mammography results immediately. Patients will be approached on the day of their first new patient visit to the Duke Cancer Center. If they are willing, they will be consented in clinic, and directed down to the lab for their first blood draw.

Diagnostic Test: Blood test

Cases: Patients with known cancer diagnosis

Patients presenting to the Duke Cancer Center for evaluation by Medical or Surgical Oncology of a newly diagnosed breast cancer will be screened for study eligibility and approached, enrolled, and consented accordingly. Patients will be approached on the day of their first new patient visit to the Duke Cancer Center. If they are willing, they will be consented in clinic, and directed down to the lab for their first blood draw.

Diagnostic Test: Blood test

Interventions

Blood test DIAGNOSTIC_TEST

Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.

Cases: Patients with known cancer diagnosis; Controls: Patients with negative screening MMG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to the Duke Cancer Center for evaluation by Medical or Surgical Oncology of a newly diagnosed breast cancer Patients presenting to Duke Radiology for routine screening mammogram

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunis.AI: lead
• Duke University: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (12)

• 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: 10.3390/cells10102567.

  PMID: 34685549 RESULT

• 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.

  PMID: 16704732 RESULT

• 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 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 RESULT

• 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 2003 Jan 9.

  PMID: 12522010 RESULT

• 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.

  PMID: 18684880 RESULT

• 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.

  PMID: 25225678 RESULT

• 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.

  PMID: 22025056 RESULT

• 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.

  PMID: 22054451 RESULT

• 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.

  PMID: 29297497 RESULT

• 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.

  PMID: 26005866 RESULT

• 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: 10.1016/j.eururo.2014.08.024. Epub 2014 Aug 24.

  PMID: 25159890 RESULT

• 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 Cancer. J Urol. 2017 Jan;197(1):67-74. doi: 10.1016/j.juro.2016.07.005. Epub 2016 Jul 14.

  PMID: 27422298 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Kirk Wojno, MD

  Immunis.AI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Nash

CONTACT

855-855-6484; amanda.nash@duke.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)