NCT07000396

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Dec 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

May 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 30, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 24, 2025

Last Update Submit

July 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between mucosal associated invariant t lymphocytes and breast cancer outcome

    The role of mucosal associated invariant t lymphocytes in breast cancer

    Baseline

Study Arms (2)

Group A

breast cancer patients

Group B

normal individual (control)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30208917BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 24, 2025

First Posted

June 2, 2025

Study Start

December 1, 2025

Primary Completion

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-05