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

NCT06447532 | Enrolling By Invitation DMC

• 1 other identifier: University of Sao Paulo
• Study Type: observational
• Target: 4,500
• Locations: 8 countries
• Sites: 13

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

Conditions

Breast Cancer

Keywords

breast cancer; machine learning; prognosis; inflammation

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival

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

Secondary Outcomes (1)

• 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

Study Arms (1)

Group I: Breast cancer

All the participants involved in our study are women who are diagnosed breast cancer and treated with surgery or neoadjuvant chemotherapy from January 1st 2013 to December 31st 2018.

Procedure: Surgery (Mastectomy or quadrantectomy)

Interventions

Surgery (Mastectomy or quadrantectomy) PROCEDURE

Surgery (mastectomy or quadrantectomy); Neoadjuvant chemotherapy

Also known as: Neoadjuvant chemotherapy

Group I: Breast cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Women diagnosed with breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the women involved in our study are patients who are diagnosed breast cancer pathologically and treated with surgery or neoadjuvant chemotherapy from January 1st 2013 to December 31st 2018.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (13)

Pablo Mandó

Buenos Aires, Buenos Aires, Argentina

Location

Rosekeila Simoes Nomeline

Uberaba, Minas Gerais, Brazil

Location

Tomás Reinert

Porto Alegre, Rio Grande do Sul, Brazil

Location

Idam Oliveira Junior

Barretos, São Paulo, Brazil

Location

César Cabello

Campinas, São Paulo, Brazil

Location

Daniel Guimaraes Tiezzi

Ribeirão Preto, São Paulo, Brazil

Location

Vasily Giannakeas

Toronto, Ontario, Canada

Location

Salma Elashwah

Cairo, Egypt

Location

Masahiro Takada

Osaka, Osaka, Japan

Location

Masakazu Toi

Tokyo, Tokyo, 113-8677, Japan

Location

Cynthia Mayte Villarreal Garza

Mexico City, Mexico

Location

Wonshik Han

Seoul, South Korea

Location

Cristina Saura

Madrid, Spain, Spain

Location

Related Publications (3)

• 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.

  PMID: 33538338 BACKGROUND

• 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.

  PMID: 37971409 BACKGROUND

• 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.

  PMID: 28286600 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Inflammation

Interventions

Surgical Procedures, Operative; Mastectomy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Afonso C Nazario, PhD

  University Federal of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Coordinator at the Department of Gynecology at EPM/UNIFESP.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: June 7, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); EG (1); BR (5); ES (1); AR (1); KR (1); ME (1); JP (2)