Breast CancerNCT05623241
MONOCENTRIC PERSPECTIVE STUDY: USE OF LIQUID BIOPSY WITH DIAGNOSTIC IMAGING
An observational study of Breast Cancer and Liquid Biopsy, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Liquid Biopsy
- What is being tested?
- Liquid Biopsy
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2022to 22 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- state of pregnancy or breastfeeding
- patients operated on for benign or inflammatory diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University "Luigi Vanvitelli"
Naples, 80127
Gianluca Gatta, +390815665202, gianluca.gatta@unicampania.it
About this study
Official title: PERSPECTIVE MONOCENTRIC STUDY: USE OF LIQUID BIOPSY AND DIAGNOSTIC IMAGING IN THE SEARCH FOR CIRCULATING TUMOR DNA IN PATIENTS WITH BREAST CANCER
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
- Being tested
- Liquid Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid BiopsyDiagnostic test
Venous blood sampling for liquid biopsy in breast cancer patients after segmentation of the lesion on mammography
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiomic of breast cancers and liquid biopsy
Detect possible relationships between breast cancers radiomic feature and genetic mutations on liquid biopsy
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start12 Sep 2022
- Primary completion15 Sep 2023 (estimated)
- Study completion22 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Gatta, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623241
- Sponsor's protocol ID
- 0023041/i
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERSPECTIVE MONOCENTRIC STUDY: USE OF LIQUID BIOPSY AND DIAGNOSTIC IMAGING IN THE SEARCH FOR CIRCULATING TUMOR DNA IN PATIENTS WITH BREAST CANCER
- ClinicalTrials.gov ID
- NCT05623241
- Acronym / sponsor ID
- 0023041/i
- Conditions
- Breast Cancer, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 22 Sep 2025 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- state of pregnancy or breastfeeding
- patients operated on for benign or inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid BiopsyVenous blood sampling for liquid biopsy in breast cancer patients after segmentation of the lesion on mammography | Diagnostic test | – |
Primary outcome
Radiomic of breast cancers and liquid biopsy
Time frame: 36 months
Detect possible relationships between breast cancers radiomic feature and genetic mutations on liquid biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Liquid Biopsy, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiomic of breast cancers and liquid biopsy (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.