MONOCENTRIC PERSPECTIVE STUDY: USE OF LIQUID BIOPSY WITH DIAGNOSTIC IMAGING

NCT05623241 | Unknown

• 1 other identifier: 0023041/i
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the diagnostic accuracy of Mammography in the morpho-structural analysis of mammographic images in breast cancer-diagnosed patients or patients in follow-up for breast cancer by extracting a number of features describing the texture and morphology of the lesions reported in the form of a structured report explicitly developed for the study. Correlation of the data obtained from evaluating the primary endpoint with the genetic/molecular analysis on liquid biopsy.

Conditions

Breast Cancer; Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

• Radiomic of breast cancers and liquid biopsy

  Detect possible relationships between breast cancers radiomic feature and genetic mutations on liquid biopsy

  36 months

Interventions

Liquid Biopsy DIAGNOSTIC_TEST

Venous blood sampling for liquid biopsy in breast cancer patients after segmentation of the lesion on mammography

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients are enrolled in mammography screening
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The liquid biopsy will be performed on all patients who undergo a mammography examination in which a malignant focal aspect has been found and who agree to participate in the study. All patients enrolled in the study will be subjected to a peripheral venous blood sample. The ctDNA will be extracted for molecular analysis and will be performed with NGS (Next Generation Sequencing) technology.

You may qualify if:

• full information on the study and signature of the informed consent
• biopsy-proven breast cancer or previous surgery for breast cancer
• willingness of the patient to undergo liquid biopsy

You may not qualify if:

• state of pregnancy or breastfeeding
• patients operated on for benign or inflammatory diseases

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University "Luigi Vanvitelli"

Naples, 80127, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: November 21, 2022
• Study Start: September 12, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 22, 2025
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

IT (1)