Clinical trial NCT05857111: Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)
Official title: Observational Prospective Study, to Validate the Effectiveness of CELBREA® Compared to the Detection Results in Symptomatic Women or Those With Diagnostic Doubt (DETECT-BH)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Disease
Benign Breast Disease
Breast Cancer
Keywords: breast symptoms
diagnostic doubt
Celbrea
Breast Thermal Activity Indicator
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Welwaze Medical Inc.
First posted: 2023-05-12
Enrollment: 255
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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.

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: