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

Observational Prospective Study, to Validate the Effectiveness of CELBREA® Compared to the Detection Results in Symptomatic Women or Those With Diagnostic Doubt (DETECT-BH)

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 Overview

• Status: Enrolling by invitation
• Conditions: Breast Cancer; Benign Breast Disease; Breast Disease
• Intervention / Treatment: Device: Celbrea

• Study Type: Observational
• Enrollment (Anticipated): 255

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Celbrea; The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility.; Other Names: Breast Thermal Activity Indicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Jose Ignacio Sánchez
• Collaborators: Welwaze Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Anticipated): July 7, 2023
• Study Completion (Anticipated): July 7, 2023

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: breast symptoms; diagnostic doubt; Celbrea; Breast Thermal Activity Indicator
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Fibrocystic Breast Disease
• Other Study ID Numbers: PI-5330; 2022.296 (Other Identifier: Hospital Universitario La Paz)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes