Breast CancerNCT07000396
The Role of Mucosal Associated Invariant t Lymphocytes in Breast Cancer
An observational study of Breast Cancer, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients admitted at South Egypt cancer institute who diagnosed as breast cancer based on full clinical, radiologic and pathologic assays
Who may be able to join
- Female patients admitted at South Egypt cancer institute who diagnosed as breast cancer based on full clinical, radiologic and pathologic assays
Who cannot join
- Patients receive any anti-cancer therapy.
- Patients diagnosed with other concomitante cancer or chronic disease
About this study
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]
Read more
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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | breast cancer patients | |
| Group B | normal individual (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between mucosal associated invariant t lymphocytes and breast cancer outcome
The role of mucosal associated invariant t lymphocytes in breast cancer
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mostafa Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000396
- Sponsor's protocol ID
- MAIT Cells in Breast Cancer
- Status last verified
- May 2025
- First submitted
- 24 May 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30208917
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mucosal Associated Invariant t Lymphocytes in Breast Cancer
- ClinicalTrials.gov ID
- NCT07000396
- Acronym / sponsor ID
- MAIT Cells in Breast Cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –breast cancer patients |
| Group B | – | –normal individual (control) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients admitted at South Egypt cancer institute who diagnosed as breast cancer based on full clinical, radiologic and pathologic assays
Key inclusion criteria (1 listed)
- Female patients admitted at South Egypt cancer institute who diagnosed as breast cancer based on full clinical, radiologic and pathologic assays
Key exclusion criteria (2 listed)
- Patients receive any anti-cancer therapy.
- Patients diagnosed with other concomitante cancer or chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between mucosal associated invariant t lymphocytes and breast cancer outcome
Time frame: Baseline
The role of mucosal associated invariant t lymphocytes in breast cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Results publication: PubMed 30208917Zumwalde 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between mucosal associated invariant t lymphocytes and breast cancer outcome (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.