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

NCT05857111 | Unknown FDA Device

• 2 other identifiers: PI-53302022.296
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Disease; Benign Breast Disease; Breast Cancer

Keywords

breast symptoms; diagnostic doubt; Celbrea; Breast Thermal Activity Indicator

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Celbrea DEVICE

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

Also known as: Breast Thermal Activity Indicator

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Capable of following the instructions necessary for the study.
• Have signed the informed consent form.

You may not qualify if:

• Women who are pregnant or lactating at the time of the study.
• 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.

Sponsors & Collaborators

• Jose Ignacio Sánchez: lead
• Welwaze Medical Inc.: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Breast Diseases; Cystic Fibrosis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Breast Unit - Hospital Universitario La Paz - Madrid - Spain

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 12, 2023
• Study Start: January 18, 2023
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

ES (1)