Ireland
--:--IST
Enrolling by invitation Observational

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

NCT06447532 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2024-08-01
Last updated
2025-03-12

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Surgery (Mastectomy or quadrantectomy)

Surgery (Mastectomy or quadrantectomy): Surgery (mastectomy or quadrantectomy); Neoadjuvant chemotherapy

Study 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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • Overall survival — From the date of diagnosis to the date of death, assessed up to 120 months
    Overall survival

Trial sites (13)

FacilityCityRegionStatus
Pablo Mandó Buenos Aires Buenos Aires
Rosekeila Simoes Nomeline Uberaba Minas Gerais
Tomás Reinert Porto Alegre Rio Grande do Sul
Idam Oliveira Junior Barretos São Paulo
César Cabello Campinas São Paulo
Daniel Guimaraes Tiezzi Ribeirão Preto São Paulo
Vasily Giannakeas Toronto Ontario
Salma Elashwah Cairo Egypt
Masahiro Takada Osaka Osaka
Masakazu Toi Tokyo Tokyo
Cynthia Mayte Villarreal Garza Mexico City Mexico
Wonshik Han Seoul South Korea
Cristina Saura Madrid Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06447532 on ClinicalTrials.gov ↗ ← All trials in Spain