Observational Prospective Study, to Validate the Effectiveness of CELBREA® Compared to the Detection Results in Symptomatic Women or Those With Diagnostic Doubt (DETECT-BH)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Disease
- Sponsor
- Jose Ignacio Sánchez
- Enrollment
- 255
- Locations
- 1
- Primary Endpoint
- Effectiveness defined as sensitivity, specificity, positive and negative predictive values, positive and negative probability quotients, and accuracy using Detection Results as comparator.
- Status
- Enrolling by Invitation
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Jose Ignacio Sánchez
Head of Breast Unit - Hospital Universitario La Paz - Madrid - Spain
Instituto de Investigación Hospital Universitario La Paz
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Effectiveness defined as sensitivity, specificity, positive and negative predictive values, positive and negative probability quotients, and accuracy using Detection Results as comparator.
Time Frame: Through study completion, an average of 1 year
Detection Result (DR): it is defined as the absence or presence of a breast pathology (benign or malignant). Positive DR: a DR will be labeled as positive (Positive DR) when the presence (diagnosis) of a breast pathology has been verified (benign or malignant). Negative DR: a DR will be labeled as negative (Negative DR) when the absence of breast pathologies has been verified. Significant Reading (CELBREA® test): A difference of 4 columns or more between corresponding segments is considered significant. Non-significant reading (CELBREA® test): a difference of 3 columns or less in any section between corresponding segments is considered non-significant.