Breast Cancer Clinical Trial
— INFLAMMATEOfficial title:
Use of Machine Learning Techniques for Serial Assessment of Systemic Inflammatory Markers in Breast Cancer Patients
Verified date | June 2024 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Active, not recruiting |
Enrollment | 4500 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Idam Oliveira Junior | Barretos | Sao Paulo |
Brazil | César Cabello | Campinas | Sao Paulo |
Brazil | Tomás Reinert | Porto Alegre | Rio Grande Do Sul |
Brazil | Daniel Guimaraes Tiezzi | Ribeirão Preto | Sao Paulo |
Brazil | Rosekeila Simoes Nomeline | Uberaba | Minas Gerais |
Canada | Vasily Giannakeas | Toronto | Ontario |
Italy | Claudio Vernieri | Milan | |
Japan | Masahiro Takada | Osaka | |
Japan | Masakazu Toi | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo | Barretos Cancer Hospital, Emory University, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Kansai Medical University, Kyoto University, Santa Casa de Porto Alegre, University of Campinas, Brazil, University of Sao Paulo, Women's College Hospital |
Brazil, Canada, Italy, Japan,
Choi E, Bahadori MT, Schuetz A, Stewart WF, Sun J. Doctor AI: Predicting Clinical Events via Recurrent Neural Networks. JMLR Workshop Conf Proc. 2016 Aug;56:301-318. Epub 2016 Dec 10. — View Citation
Faria SS, Giannarelli D, Cordeiro de Lima VC, Anwar SL, Casadei C, De Giorgi U, Madonna G, Ascierto PA, Mendoza Lopez RV, Chammas R, Capone M. Development of a Prognostic Model for Early Breast Cancer Integrating Neutrophil to Lymphocyte Ratio and Clinical-Pathological Characteristics. Oncologist. 2024 Apr 4;29(4):e447-e454. doi: 10.1093/oncolo/oyad303. — View Citation
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Overall survival | From the date of diagnosis to the date of death, assessed up to 120 months | |
Secondary | Disease free survival | Disease-free survival | From the date of diagnosis to the date of first progression (local recurrence of tumor or distant metastasis), assessed up to 60 months |
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