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

Breast Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809128
• Other study ID #: 3/19
• Status: Recruiting
• Start date: May 29, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2023
• Source: IRCCS SYNLAB SDN
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2023
• Gender: Female
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Patients
• Breast Neoplasms

Intervention

Other:
• surgery for breast cancer and imaging test evaluations
At the time of surgery, having completed the evaluation extemporaneous of the surgical piece, tissue samples will be collected to be stored from the material exceeding the completion of the patients' diagnosis. In addition, paramenters that can be extracted from radiodiagnostic images will be evaluated

Locations

Country	Name	City	State
Italy	IRCCS Synlab SDN	Naples

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS SYNLAB SDN

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiparametric flow cytometry analyses of Custer of Differentiation (CD) proteins expression on tumor infiltrating lymphocytes	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.	1-24 months
Primary	Analysis of gene expression profiles of cancer cells	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	1-24 months
Primary	Extraction of features from radiological images to be used as biomarkers.	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.	1-36 months
Primary	Bioinformatics analysis	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.	37-48 months