Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Path… (NCT05857111) | Clinical Trial Compass
UnknownNot Applicable
Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)
Spain255 participantsStarted 2023-01-18
Plain-language summary
This is an observational, prospective, and transversal study, designed to evaluate the effectiveness of CELBREA® in women from the local community coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of discomfort, breast symptoms, or because they have been sent for specialized evaluation because of a diagnostic doubt, providing actualized data on the effectiveness of the device within the context of the real-world scenario. Because of its transverse nature, the observation period will be limited to the necessary amount of time to perform the initial consult, additional tests when prescribed by the physician, and the CELBREA® test.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Women ≥ 18 years old coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of:
. Capable of following the instructions necessary for the study.
. Have signed the informed consent form.
Exclusion criteria
. Women who are pregnant or lactating at the time of the study.
. Women suffering from one of the following breast pathologies:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is testing how accurately CELBREA® can detect breast problems compared to standard diagnostic methods, can you explain how that accuracy data might actually change the way my own breast issue gets diagnosed or managed?
2This trial's recruitment status is listed as 'unknown' — can you find out whether it's still actively enrolling patients, and whether it would even be an option worth pursuing for my situation?
3Because this is a diagnostic study rather than a treatment trial, does participating mean I would still receive the same standard care and imaging I'd normally get, or could enrollment affect my usual diagnostic workup?
4The trial is measuring things like sensitivity and specificity, which are about how well CELBREA® catches real cases versus false alarms — given my specific symptoms or imaging results, how confident are you in my current diagnosis without a tool like this?
5Are there standard diagnostic approaches — like a biopsy, MRI, or ultrasound — that you'd recommend I complete first before considering whether a study like this makes sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness defined as sensitivity, specificity, positive and negative predictive values, positive and negative probability quotients, and accuracy using Detection Results as comparator.
Timeframe: Through study completion, an average of 1 year