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

NCT05809128 | Unknown

• 1 other identifier: 3/19
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Patients

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Interventions

surgery for breast cancer and imaging test evaluations OTHER

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

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS SYNLAB SDN: lead

Study Sites (1)

IRCCS Synlab SDN

Naples, 80143, Italy

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 12, 2023
• Study Start: May 29, 2019
• Primary Completion: January 31, 2023
• Study Completion: June 30, 2025
• Last Updated: March 25, 2024

Record last verified: 2023-03

Locations

IT (1)