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Use of Machine Learning Techniques for Serial Assessment of Systemic Inflammatory Markers in Breast Cancer Patients

Use of Machine Learning Techniques for Serial Assessment of Systemic Inflammatory Markers in Breast Cancer Patients

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06447532
Acronym
INFLAMMATE
Enrollment
4500
Registered
2024-06-07
Start date
2024-08-01
Completion date
2027-02-28
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, machine learning, prognosis, inflammation

Brief summary

Breast cancer is the most common cancer in women globally, with 2.3 million new cases diagnosed in 2020. Hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer is the most prevalent subtype, comprising 69% of all breast cancers in the USA. Within the tumor immune microenvironment, a higher intensity of myeloid cell infiltration and low levels of lymphocyte infiltration have been associated with worse outcomes. Markers in peripheral blood have emerged as predictive biomarkers that can be easily obtained non-invasively and at low cost. Experiments have confirmed the relative components of these tests (such as the immune cells) directly or indirectly participated in tumour occurrence, development, and immune escape, underscoring the potential use of laboratory tests as tumour biomarkers

Detailed description

In breast cancer, increased neutrophil levels and decreased lymphocyte levels in peripheral blood are associated with worse overall survival (OS). In HR+, HER2- metastatic breast cancers, low pretreatment NLR and high pretreatment absolute lymphocyte count (ALC) were related with better progression-free survival (PFS) and OS. The development of predictive models, based on machine learning (ML) algorithms it has been used in prognostication and assist in the diagnosis of different types of cancer. Although regular laboratory tests have potential to be breast cancer biomarkers, a single test is yet to provide adequate sensitivity or specificity. Artificial intelligence (AI) could help with integrating data from multiple tests to aid diagnosis. Technical improvements such as data storage capacity, computing power, and better algorithms mean that ML can process clinically meaningful information from laboratory test data. Models' generalisability and stability still need to be confirmed, in view of limitations such as the absence of various pathological types, small cohorts, and lack of external validation. Therefore, a competitive model is also essential to achieve more accurate stratification of patients with breast cancer. The purpose of this retrospective multicentre study is to systematically evaluate the ability of laboratory tests to predict breast cancer, and develop a robust and generalisable model to assist in identifying patients with breast cancer.

Interventions

PROCEDURESurgery (Mastectomy or quadrantectomy)

Surgery (mastectomy or quadrantectomy); Neoadjuvant chemotherapy

Sponsors

Kansai Medical University
CollaboratorOTHER
University of Sao Paulo
CollaboratorOTHER
Kyoto University
CollaboratorOTHER
Barretos Cancer Hospital
CollaboratorOTHER
Women's College Hospital
CollaboratorOTHER
Emory University
CollaboratorOTHER
University of Campinas, Brazil
CollaboratorOTHER
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
CollaboratorOTHER
Instituto Nacional de Cancer, Brazil
CollaboratorOTHER_GOV
Universidade Federal do Triangulo Mineiro
CollaboratorOTHER
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
CollaboratorOTHER
Hospital Vall d'Hebron
CollaboratorOTHER
Mansoura University
CollaboratorOTHER
Seoul National University
CollaboratorOTHER
Federal University of São Paulo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Women patients with age between 18 and 75 years old; * Invasive breast carcinoma patients diagnosed by pathology ; * Patients diagnosed between 1 January 2013 and 31 December 2018; * Have a complete blood count performed before the surgical intervention (mastectomy or conservative breast surgery) or neoadjuvant chemotherapy;

Exclusion criteria

Presence of hematological disorders; * Bilateral breast cancer; * Male; * Karnofsky Performance Status Score \< 70'; * Inflammatory breast cancer and in situ carcinoma; * Pregnancy or breastfeeding; * Evidence of local or distant recurrence.

Design outcomes

Primary

MeasureTime frameDescription
Overall survivalFrom the date of diagnosis to the date of death, assessed up to 120 monthsOverall survival

Secondary

MeasureTime frameDescription
Disease free survivalFrom the date of diagnosis to the date of first progression (local recurrence of tumor or distant metastasis), assessed up to 60 monthsDisease-free survival

Countries

Argentina, Brazil, Canada, Egypt, Japan, Mexico, South Korea, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026