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Trial Title:
MONOCENTRIC PERSPECTIVE STUDY: USE OF LIQUID BIOPSY WITH DIAGNOSTIC IMAGING
NCT ID:
NCT05623241
Condition:
Breast Cancer
Liquid Biopsy
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Liquid Biopsy
Description:
Venous blood sampling for liquid biopsy in breast cancer patients after segmentation of
the lesion on mammography
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Patients are enrolled in mammography screening
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University "Luigi Vanvitelli"
Address:
City:
Naples
Zip:
80127
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gianluca Gatta
Phone:
+390815665202
Email:
gianluca.gatta@unicampania.it
Start date:
September 12, 2022
Completion date:
September 22, 2025
Lead sponsor:
Agency:
University of Campania "Luigi Vanvitelli"
Agency class:
Other
Source:
University of Campania "Luigi Vanvitelli"
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05623241
