Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06447532

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

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Pablo Mandó, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery (Mastectomy or quadrantectomy)

Procedure

Surgery (mastectomy or quadrantectomy); Neoadjuvant chemotherapy

Other names: Neoadjuvant chemotherapy

Primary outcomes

  1. Overall survival

    Time frame: From the date of diagnosis to the date of death, assessed up to 120 months

    Overall survival

Secondary outcomes

  1. Disease free survival

    Time frame: From the date of diagnosis to the date of first progression (local recurrence of tumor or distant metastasis), assessed up to 60 months

    Disease-free survival

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

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

Registry information

Acronym: INFLAMMATE

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
Jun 7, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.