Multidisciplinary Approach to Breast Cancer Through the Study of Altered Transcriptomic and Immune Accompanied by the Identification of Extractable Markers From the Radiodiagnostic Bioimaging

Recruiting

• Conditions: Breast Cancer Patients

• Registration Number: NCT05809128
• Lead Sponsor: IRCCS SYNLAB SDN

Brief Summary

Prospective observational study for onco-immunologic characterization and by bioimaging of breast neoplastic tissue of patients operated for breast cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Primary Completion: 2023-01-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-12
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Clinical diagnosis of breast cancer.
• patients 25 to 80 years of age

Exclusion Criteria

• Patients who refuse to participate in the study;
• Patients who do not fall within the age range mentioned above

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bioinformatics analysis	37-48 months	The correlations between the cytofluorimetric characterization of TILs and the quantitative parameters extracted from radiological images will be performed using different software such as Graphpad or ER softwares.
Analysis of gene expression profiles of cancer cells	1-24 months	The following area of study is focused on the study by molecular biology of samples of cancerous and healthy tissue that will be possible to obtain from the subjects participating in the study. For that phase, the type of instrumentation will be determined according to the amount of nucleic acids extracted from the tissues. In fact, samples that will allow recovery of high amounts of RNA and with a good degree of purity will be able to be used for studies carried out with next generation sequencing such as, for example, Ion Torrent S5. In the case of samples in which the RNA is difficult to extract or of low quality, methods such as real time polymerase chain reaction (PCR) in multiplex mode
Extraction of features from radiological images to be used as biomarkers.	1-36 months	Radiological images from High-field MRI, multilayer CT, hybrid systems such as PET-CT and PET-MRI will be use to extract quantitative parameters of the lesion and the other structures of interest. An automatic segmentation , or alternatively, a manual segmentation by an experienced radiologist or experienced nuclear physician will be performe.
Multiparametric flow cytometry analyses of Custer of Differentiation (CD) proteins expression on tumor infiltrating lymphocytes	1-24 months	The following phase of the study aims to go to evaluate the immunology of breast cancer patients compared with the control. In particular we will perfome an accurate characterization in flow cytometry of the cells present in the peripheral blood and of the immune component infiltrating the tumor (tumor infiltrating lymphocytes). The different components of tumor infiltrating lymphocytes will be assessed using the following antibodies: CD45 , CD8, CD4,CD3, HLA-DR, CD19 , CD 326 (EpCAM) ,CD56 , CD14 and CD16.

Trial Locations

Locations (1)

IRCCS Synlab SDN; 🇮🇹 Naples, Italy