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RecruitingNCT05623241Updated Nov 21, 2022

MONOCENTRIC PERSPECTIVE STUDY: USE OF LIQUID BIOPSY WITH DIAGNOSTIC IMAGING

An observational study in Breast Cancer and Liquid Biopsy, sponsored by University of Campania Luigi Vanvitelli. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-21.

Sponsored by University of Campania Luigi Vanvitelli · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer
  • Liquid Biopsy

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 200 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testLiquid Biopsy

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

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What researchers measure

Primary outcomes

  1. Radiomic of breast cancers and liquid biopsy

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

    Time frame: 36 months

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05623241
Lead sponsor
University of Campania Luigi Vanvitelli
Responsible party
Gianluca Gatta (Researcher, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
Nov 21, 2022
Start date
Sep 12, 2022
Primary completion
Sep 15, 2023 (estimated)
Completion
Sep 22, 2025 (estimated)
Last update
Nov 21, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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