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NCT05623241 Clinical Trial

MONOCENTRIC PERSPECTIVE STUDY: USE OF LIQUID BIOPSY WITH DIAGNOSTIC IMAGING

Breast Cancer Clinical Trial

Official title:
PERSPECTIVE MONOCENTRIC STUDY: USE OF LIQUID BIOPSY AND DIAGNOSTIC IMAGING IN THE SEARCH FOR CIRCULATING TUMOR DNA IN PATIENTS WITH BREAST CANCER

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05623241
Other study ID # 0023041/i
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 12, 2022
Est. completion date September 22, 2025

Study information
Verified date November 2022
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 22, 2025
Est. primary completion date September 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - state of pregnancy or breastfeeding - patients operated on for benign or inflammatory diseases

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Liquid Biopsy
Venous blood sampling for liquid biopsy in breast cancer patients after segmentation of the lesion on mammography

Locations
Country Name City State
Italy University "Luigi Vanvitelli" Naples

Sponsors (1)
Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiomic of breast cancers and liquid biopsy Detect possible relationships between breast cancers radiomic feature and genetic mutations on liquid biopsy 36 months
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