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

Jose Ignacio Sánchez

Status: Invitation-only

Conditions: Breast Cancer; Breast Disease; Benign Breast Disease

Treatments: Device: Celbrea

Study type: Observational

Funder types: Other

Identifiers

NCT05857111

PI-5330

2022.296 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 255 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

255 participants in 1 patient group

Study population

Description:

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.

Treatment:

Device: Celbrea