TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients
NCT ID: NCT05206396
Last Updated: 2023-07-24
Study Results
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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UNKNOWN
270 participants
OBSERVATIONAL
2022-07-24
2024-09-30
Brief Summary
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The tumor microenvironment, which includes extracellular matrix and stromal cells, is a key factor in tumorigenicity and the prediction of the efficacy of immunotherapy, conventional chemotherapy, and other anticancer therapies. Tumor-infiltrating lymphocytes (TILs), one of the most important components of the tumor microenvironment, were reported to predict the response to NAC both for tumors and axillary lymph nodes in breast cancer patients. This study is conducted to examine the relationship between tumor-infiltrating lymphocytes (categorized into three levels) and the pathologic complete response to neoadjuvant systemic therapy in breast cancer patients, and to examine the relationship between TILs and 1-year invasive disease-free survival (IDFS).
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Detailed Description
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The tumor microenvironment, which includes extracellular matrix and stromal cells, is a key factor in tumorigenicity and the prediction of the efficacy of immunotherapy, conventional chemotherapy, and other anticancer therapies. Tumor-infiltrating lymphocytes (TILs), one of the most important components of the tumor microenvironment, were reported to predict the response to NAC both for tumors and axillary lymph nodes in breast cancer patients. This study is conducted to examine the relationship between tumor-infiltrating lymphocytes (categorized into three levels) and the pathologic complete response to neoadjuvant systemic therapy in breast cancer patients, and to examine the relationship between TILs and 1-year invasive disease-free survival (IDFS).
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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TIL in breast cancer patients who completed neoadjuvant therapy
* Tumour infiltrating lymphocytes will be examined on pre-existing histopathologic samples.
* Data will be extracted from the files of the patients including:
* Demographic data, clinicopathologic data, pathologic complete response, and date of last follow up.
TIL assessment in pre-existing histopathological specimens
TIL assessment in pre-existing histopathological specimens and their relation to complete pathological response and 1-year invasive disease-free interval
Interventions
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TIL assessment in pre-existing histopathological specimens
TIL assessment in pre-existing histopathological specimens and their relation to complete pathological response and 1-year invasive disease-free interval
Eligibility Criteria
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Inclusion Criteria
* Histologically proven invasive breast cancer
* All patients diagnosed with breast cancer except T1N0 and Metastatic breast cancer
* Patients who completed their systemic neoadjuvant therapy
Exclusion Criteria
* Patients who started but didn't complete neoadjuvant systemic therapy
* Patients who didn't undergo surgery after neoadjuvant systemic therapy
* Pregnant patients
18 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Iman Aly
Professor
Principal Investigators
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Iman Sharawy, MD
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Locations
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Faculty of Medicine, Ain Shams University
Cairo, , Egypt
Countries
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Central Contacts
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Ahmad Gab Allah, MD
Role: CONTACT
Facility Contacts
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Iman Sharawy, MD
Role: primary
Other Identifiers
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R148/2021
Identifier Type: -
Identifier Source: org_study_id
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