Role of TREM-1 as a Novel Biomarker in HER-2 Negative Breast Cancer: a Molecular and Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- : assess prognostic significance of TREM-1 expression at baseline and post neo-adjuvant treatment regards DFS & OS
Study Overview
Brief Summary
Global cancer statistics by world region for the year 2022 estimated breast cancer the 2nd cause of new cancer cases (11.6%). (1) Approximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth factor receptor 2 (HER2)-negative. (2) Most breast cancer cases can be cured by multimodality treatment, although cure rates vary by clinical stage, subtype and the clinical behavior of cancer which affected by the composition of pro- and anti-tumor immune mediators within the tumor microenvironment. (3, 4) Immune gene signatures in breast tumors -that comprise genes with specialized roles in immune biology- Significantly, have been shown to correlate with patient survival outcomes. (5-8)chemotherapy responsiveness. (7, 9), and more recently, response to immunotherapies.(10-12)One such candidate, the gene encoding Triggering Receptor Expressed on Myeloid Cells (TREM)-1, which emerged as a robust therapy predictive and prognostic marker. TREM1 encodes a type I trans-membrane receptor of the Ig superfamily expressed by effectors of innate immunity including neutrophils, monocytes and macrophages. The TREM-1 receptor is known to augment inflammatory signaling in response to infectious pathogens by promoting release of cytokines that modulate the activation, recruitment and survival of myeloid and lymphoid cells. (13) In this study we hope to gain a better understanding of TREM-1 clinical and molecular relevance in HER2 negative BC either triple negative or hormonal positive which represent significant subset that lack target therapeutic options, evaluating its effect as predictive and prognostic marker and so the potential implications for patient management.
Detailed Description
a prospective observational cohort study on the role of TREM-1 as a novel immune biomarker in HER-2 breast cancer it's a molecular and clinical study. our aim is to assess prognostic significance of TREM-1 expression at baseline and post neo-adjuvant treatment regards DFS & OS and to quantify TREM-1 expression and correlate its level with clinical and pathological response to neo-adjuvant treatment. and evaluate its association with immune cells (eg. monocytes and neutrophils)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •female patient aged < 18 yrs. old
- •histological proven breast cancer
- •HER-2 negative (hormonal positive or triple negative)
- •planned to receive neo-adjuvant therapy
- •complete clinical, radiological and therapeutic data
Exclusion Criteria
- •metastatic breast cancer
- •HER-2 positive
- •incomplete clinical, radiological or therapeutic data
Outcomes
Primary Outcomes
: assess prognostic significance of TREM-1 expression at baseline and post neo-adjuvant treatment regards DFS & OS
Time Frame: follow up patients over 2 years
prognostic significance of TREM-1 expression at baseline and post neo-adjuvant treatment regards DFS \& OS
Secondary Outcomes
No secondary outcomes reported
Investigators
Rahma Esam Salama Esawi
Role of TREM-1 as a novel biomarker in HER-2 breast cancer : a molecular and clinical study
Assiut University
