Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)

• Conditions: Breast Disease; Breast Cancer; Benign Breast Disease
• Interventions: Device: Celbrea

• Registration Number: NCT05857111
• Lead Sponsor: Jose Ignacio Sánchez

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-18
• Study First Submitted: 2023-04-25
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 255

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Celbrea	An estimate of 255 adult women (≥ 18 years old) who come 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 will be included.

Primary Outcome Measures

Name	Time	Method
Effectiveness defined as sensitivity, specificity, positive and negative predictive values, positive and negative probability quotients, and accuracy using Detection Results as comparator.	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.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain