Clinical trial NCT07000396: The Role of Mucosal Associated Invariant t Lymphocytes in Breast Cancer
Official title: The Role of Mucosal Associated Invariant t Lymphocytes in Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-06-02
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients admitted at South Egypt cancer institute who diagnosed as breast cancer based on full clinical, radiologic and pathologic assays

Brief summary: Evaluation of MAIT cells in patient recently diagnosed as cancer breast and its correlation with clinical outcome.

Mucosal Associated Invariant T cells are a population of unconventional T cells which are enriched in mucosal tissues such as the lung and gut but are also present in other tissues including the skin, adipose tissue and the liver \[4,5,6,7\]. Unlike conventional T cells, MAIT cells are not restricted by MHC but recognize the MHC-related protein MR1. MAIT cells express a semi-invariant TCR α-chain (Vα7.2-Jα33/20/12 in humans) and a limited repository of TCR-β chains, mostly from the TRBV20 and TRBV6 gene families \[8,9\]

MAIT cells can also be activated independent of TCR engagement, via pro-inflammatory cytokines such as IL-18 \[10,11,12\]. Upon activation, MAIT cells can rapidly respond, producing a milieu of cytokines including interferon-gamma , tumor necrosis factor alpha and interleukin-17 \[11,14\]. MAIT cell cytokine profiles can vary depending on their tissue localization \[15\].

Peripheral MAIT cells are potent producers of IFNγ and TNFα, whereas IL-17 producing MAIT cells are rare in the periphery but are more abundant in, for example, the female genital mucosa \[16\]. In addition to cytokine production, A central role in immune protection against cancer is played by T lymphocytes, particularly CD8+ T cells .Their infiltration in tumor cell nests is usually associated with a favorable prognosis and may predict outcome of therapies with drugs that block immune inhibitory receptors (checkpoint blockade.

A recent meta-analysis reported that tumor-infiltrating CD8+ lymphocytes can be identified in 48% of all breast cancers .Interestingly, triple-negative breast cancers show the highest incidence of lymphocyte predominance. Moreover, TILs were found to be prognostic in triple-negative breast cancer, and higher levels of TILs were predictive for trastuzumab benefit in HER2+ disease. These findings suggest that therapies that enforce immune responses could potentially improve patient survival.


Eligibility criteria: Inclusion Criteria:

* Female patients admitted at South Egypt cancer institute who diagnosed as breast cancer based on full clinical, radiologic and pathologic assays

Exclusion Criteria:

1. Patients receive any anti-cancer therapy.
2. Patients diagnosed with other concomitante cancer or chronic disease

Primary outcomes:
measure: Relation between mucosal associated invariant t lymphocytes and breast cancer outcome
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zumwalde NA, Haag JD, Gould MN, Gumperz JE. Mucosal associated invariant T cells from human breast ducts mediate a Th17-skewed response to bacterially exposed breast carcinoma cells. Breast Cancer Res. 2018 Sep 12;20(1):111. doi: 10.1186/s13058-018-1036-5.