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

Breast Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05857111
• Other study ID #: PI-5330
• Secondary ID: 2022.296
• Status: Enrolling by invitation
• Start date: January 18, 2023
• Est. completion date: July 7, 2023

Study information

• Verified date: May 2023
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 255
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Breast Disease
• Breast Cancer
• Breast Disease
• Breast Diseases

Intervention

Device:
• Celbrea
The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Jose Ignacio Sánchez	Welwaze Medical Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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