Role of Triggering Receptor Expressed on Myeloid Cells (TREM-1) as a Novel Biomarker in Human Epidermal Growth Factor Receptor -2 (HER-2) Negative Breast Cancer: a Molecular and Clinical Study

NCT ID: NCT06950671

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-15

Study Completion Date

2029-09-30

Brief Summary

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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

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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)

Conditions

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Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Invasive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role collaborator

Rahma Esam Salama Esawi

OTHER

Sponsor Role lead

Responsible Party

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Rahma Esam Salama Esawi

Role of TREM-1 as a novel biomarker in HER-2 breast cancer : a molecular and clinical study

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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summar mohamed summar el-morshidy, lecturer

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut University Hospitals

Asyut, Egypt, Egypt

Site Status

Countries

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Egypt

Central Contacts

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rahma esawi Rahma E.Esawi, assistant lecturer

Role: CONTACT

+201020597669

Facility Contacts

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Assiut AUS

Role: primary

0884750620

References

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Pullikuth AK, Routh ED, Zimmerman KD, Chifman J, Chou JW, Soike MH, Jin G, Su J, Song Q, Black MA, Print C, Bedognetti D, Howard-McNatt M, O'Neill SS, Thomas A, Langefeld CD, Sigalov AB, Lu Y, Miller LD. Bulk and Single-Cell Profiling of Breast Tumors Identifies TREM-1 as a Dominant Immune Suppressive Marker Associated With Poor Outcomes. Front Oncol. 2021 Dec 8;11:734959. doi: 10.3389/fonc.2021.734959. eCollection 2021.

Reference Type BACKGROUND
PMID: 34956864 (View on PubMed)

Related Links

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Other Identifiers

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novel biomarker in cancer

Identifier Type: -

Identifier Source: org_study_id

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