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Identifier les schémas respiratoires des personnes atteintes d'un cancer du sein

15 septembre 2026 mis à jour par: Breathe BioMedical Inc

Utilisation de la spectroscopie infrarouge pour analyser les composés organiques volatils présents dans l'haleine des patientes atteintes d'un cancer du sein

Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection.

Women with mammogram-confirmed breast tissue density undergoing standard-of-care breast cancer screening will be invited to participate. Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators. Breath samples will be collected prior to standard of care biopsy or MRI, and patients will be stratified into the case or control group based on their test results.

The primary goal of this project is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical's cavity ring-down spectrometer to further develop Breathe BioMedical's technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women aged 40 to 74.

Secondarily, this project aims to identify patterns of VOCs that are either over- or under-represented in participants with breast cancer when compared to the breath profiles of participants without breast cancer. This project will also assess performance characteristics of the technology (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses. This project aims to understand intra-subject variability by exploring differences in breath signatures before and after definitive management of breast cancer, including surgical resection.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Cancer du sein

Type d'étude

Observationnel

Inscription (Estimé)

5175

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Sandra Veenstra
Numéro de téléphone: 234 (506) 855-2400
E-mail: sandra.veenstra@breathebiomedical.com

Lieux d'étude

Canada
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 2Z3
    - Recrutement
    - Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
    - Contact:
      
      Jocelyne Hébert, MD
      
      Numéro de téléphone: 506-862-7966
    - Chercheur principal:
      
      Jocelyne Hébert, MD
États-Unis
- District of Columbia
  - Washington D.C., District of Columbia, États-Unis, 20037
    - Recrutement
    - GW Comprehensive Breast Center
    - Contact:
      
      Geoffrey Rutledge, MD
      
      E-mail: grutledge@mfa.gwu.edu
    - Chercheur principal:
      
      Geoffrey Rutledge, MD
- Florida
  - Jacksonville, Florida, États-Unis, 32224
    - Recrutement
    - Mayo Clinic Breast Clinic
    - Contact:
      
      Clinical Trials Referral Office
      
      Numéro de téléphone: 855-776-0015
    - Chercheur principal:
      
      James Jakub, MD
- North Carolina
  - Durham, North Carolina, États-Unis, 27710
    - Recrutement
    - Duke University Medical Cente
    - Chercheur principal:
      
      Jennifer Plichta, MD
    - Contact:
      
      Jennifer Plichta, MD
      
      Numéro de téléphone: 919-684-6849
      
      E-mail: jennifer.plichta@duke.edu
- Pennsylvania
  - Pittsburgh, Pennsylvania, États-Unis, 15220
    - Pas encore de recrutement
    - Weinstein Imaging Associates
    - Contact:
      
      Danielle E Sharek, MD
      
      Numéro de téléphone: 412-440-6999
    - Chercheur principal:
      
      Danielle E Sharek, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 74 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

The target population will be women aged 40-74. Women who are scheduled for standard of care breast biopsy or MRI will be recruited, and breath will be collected prior to breast biopsy or MRI. Those with biopsy-proven primary breast cancer will be assigned to the case cohort (true positives). Subjects in this cohort who are proceeding to breast surgery at Mayo Clinic Florida or Duke University will be screened to provide a second breath sample, 6 months after the completion of treatment. To be eligible for the control cohort, subjects must have a negative MRI (for surveillance or diagnostic purposes with BI-RADS 1 or 2) that confirms the absence of breast cancer (true negatives). Individuals who have received an MRI up to 8 weeks prior to breath sample collection may be approached, granted inclusion and exclusion criteria are met. Subjects will be recruited from participating clinical centers in Canada and the United States.

La description

Inclusion Criteria:

Female (sex as assigned at birth);
Aged 40 - 74 years;
Mammography confirmed breast tissue density (BI-RADS density score of A, B, C or D);
Scheduled for standard of care biopsy or MRI;
Fluent in language of consent (English, Spanish, or French);
Ability to give informed consent;
Able to provide a breath sample.

Exclusion Criteria:

Prior history of breast cancer;
Previous surgical biopsy or surgical excision of breast cancer in the past six months;
History of cancer (except basal cell or squamous cell carcinoma of the skin) in the past year;
Acute respiratory infection and/or symptoms in the past seven days;
MRI BI-RADS 3 undergoing active surveillance (MRI requiring six-month follow-up).
Pregnant or become pregnant during the study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: CASE_CONTROL
Perspectives temporelles: PROSPECTIVE

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Breast Cancer Cohort Subjects with biopsy-proven primary breast cancer.
Control Cohort Subjects with a negative MRI (for surveillance or diagnostic purposes with BI-RADS 1 or 2) that confirms the absence of breast cancer.
Breast Cancer Cohort - Surgery Subjects with biopsy-proven primary breast cancer, who have undergone surgery at Mayo Clinic Florida or Duke University will be screened to provide a second breath sample. The second breath sample will be collected at least six months following the completion of all standard of care treatment (excluding adjuvant endocrine therapy and adjuvant HER2 directed monoclonal antibody such as trastuzumab).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Primary Outcome 1 Délai: 36 months	Classification performance metrics characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) derived from spectral features of exhaled alveolar breath obtained using Breathe BioMedical's cavity ring-down spectrometer in women aged 40-74.	36 months

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Secondary Outcome 1 Délai: 36 months	Discriminative features between women with breast cancer and women without breast cancer.	36 months
Secondary Outcome 2 Délai: 36 months	Features associated with breast cancer between participants with dense breast tissue and those with non-dense breast tissue.	36 months
Secondary Outcome 3 Délai: 36 months	Classification performance characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses.	36 months
Secondary Outcome 4 Délai: 36 months	Variability in features before and after definitive management of breast cancer, including surgical resection.	36 months
Secondary Outcome 5 Délai: 36 months	Pooled and analyzed de-identified data from this, previous, and future breath analysis studies to continue to develop Breathe BioMedical's technology and machine learning algorithms.	36 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Breathe BioMedical Inc

Collaborateurs

Mayo Clinic

Duke University

George Washington University

Réseau de Santé Vitalité Health Network

Weinstein Imaging Associates

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 février 2025

Achèvement primaire (Estimé)

1 février 2028

Achèvement de l'étude (Estimé)

1 février 2028

Dates d'inscription aux études

Première soumission

16 juillet 2024

Première soumission répondant aux critères de contrôle qualité