Breast DiseaseDETECT-BHNCT05857111
Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)
An observational study of Breast Disease and Benign Breast Disease, run by Jose Ignacio Sánchez at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Disease, Benign Breast Disease, Breast Cancer
- What is being tested?
- Celbrea
- Type of treatment
- Medical device
- How many people
- 255 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2023to 7 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Celbrea
- Keywords
- breast symptoms, diagnostic doubt, Celbrea, Breast Thermal Activity Indicator
- Medical subject headings
- Breast Diseases, Cystic Fibrosis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelbreaDevice
Also called Breast Thermal Activity Indicator
The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Celbrea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start18 Jan 2023
- Primary completion7 Jul 2023 (estimated)
- Study completion7 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose Ignacio Sánchez
- Sponsor type
- University, hospital or other
- Collaborators
- Welwaze Medical Inc.
- Responsible party
- Sponsor-investigator, Jose Ignacio Sánchez, Instituto de Investigación Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857111
- Sponsor's protocol ID
- PI-5330
- Other IDs
- 2022.296
- Acronym
- DETECT-BH
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05857111
- Acronym / sponsor ID
- DETECT-BH / PI-5330
- Conditions
- Breast Disease, Benign Breast Disease, Breast Cancer
- Keywords
- breast symptoms, diagnostic doubt, Celbrea, Breast Thermal Activity Indicator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Jose Ignacio SánchezUniversity, hospital or other
- Collaborators
- Welwaze Medical Inc.
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 7 Jul 2023 (estimated)
- Study completion
- 7 Jul 2023 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Device: CelbreaAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Women ≥ 18 years old coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of:
- Capable of following the instructions necessary for the study.
- Have signed the informed consent form.
Key exclusion criteria (8 listed)
- Women who are pregnant or lactating at the time of the study.
- Women suffering from one of the following breast pathologies:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelbreaAlso: Breast Thermal Activity IndicatorThe test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility. | Device | Study population |
Primary outcome
Effectiveness defined as sensitivity, specificity, positive and negative predictive values, positive and negative probability quotients, and accuracy using Detection Results as comparator.
Time frame: Through study completion, an average of 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Disease and Benign Breast Disease, run by Jose Ignacio Sánchez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness defined as sensitivity, specificity, positive and negative predictive values, positive and negative probability quotients, and accuracy using Detection Results as comparator. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.