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

Jose Ignacio Sánchez255 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

255

Conditions

Breast Disease Benign Breast Disease Breast Cancer

Interventions

CelbreaDEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

INCLUSION CRITERIA 1. Women ≥ 18 years old coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of: * Discomfort or breast symptoms including, but not limited to, signs or symptoms detected through a self-examination, changes of color or shape in the nipple, nipple discharge, change of appearance or color of breast skin, lumps, etc. * Refered for evaluation because of diagnostic doubt. 2. Capable of following the instructions necessary for the study. 3. Have signed the informed consent form. EXCLUSION CRITERIA: 1. Women who are pregnant or lactating at the time of the study. 2. Women suffering from one of the following breast pathologies: * Personal history of breast cancer, previous or current. * Current chemotherapy or radiotherapy for any type of cancer. * History of breast surgery (reductive, reconstructive, mastectomy, lumpectomy, and others). * Fever. * Swelling or local infections on the breasts. * Open wounds in breast skin.

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.

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.

Time frame: Through study completion, an average of 1 year