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

Study acronym: INFLAMMATE
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Trial status: Active, Not Recruiting to Enrolling by Invitationv2 Show 4 more changesShow less
    • Start date: Apr 1, 2024 to Aug 1, 2024
    • Study sites: 9 to 13
    • Study completion date: Dec 31, 2024 to Feb 2027
    • Collaborators: 9 to 14
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06447532
Lead Sponsor Federal University of São Paulo
Collaborators: Kansai Medical University, University of Sao Paulo, Kyoto University, Barretos Cancer Hospital, Women's College Hospital, Emory University, University of Campinas, Brazil, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno, Instituto Nacional de Cancer, Brazil, Universidade Federal do Triangulo Mineiro, Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud, Hospital Vall d'Hebron, Mansoura University, Seoul National University
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Inflammation
Enrollment 4,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov