Breath Test to Predict Breast Cancer and Outcome of Mammography

NCT04755829 | Unknown

• 1 other identifier: M2020 UK01
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 3

Brief Summary

To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.

Conditions

Breast Cancer; Abnormal Mammogram, Unspecified

Keywords

screening mammography; biomarker of breast disease

Outcome Measures

Primary Outcomes (2)

• BREATH TEST TO PREDICT BREAST CANCER

  Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an abnormal mammogram.

  2 years

• BREATH TEST TO PREDICT OUTCOME OF MAMMOGRAPHY

  Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an biopsy-proven breast cancer

  2 years

Study Arms (2)

Group 1

Normal screening mammogram (BIRADS 1 or 2)

Device: BreathX test for breath VOCs

Group 2

Abnormal screening mammogram (BIRADS 3 to 6)

Device: BreathX test for breath VOCs

Interventions

BreathX test for breath VOCs DEVICE

Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Phase 1 Model-building phase (unblinded) Subjects will be enrolled in two groups: Group 1. Normal screening mammogram (BIRADS 1 or 2) Group 2. Abnormal screening mammogram (BIRADS 3 to 6) Phase 2 Model-testing phase (blinded) Subjects will be enrolled in two groups: Group 3. Normal screening mammogram (BIRADS 1 or 2) Group 4. Abnormal screening mammogram (BIRADS 3 to 6)

You may qualify if:

• Female aged 18 years or older
• Understands the study, and is willing to give written informed consent to participate
• If a screening mammogram was performed during the preceding six month period, then the results were reported as normal (BIRADS 1 or 2)
• If a screening mammogram was not performed during the preceding six month period, then approves collection of the results of a screening mammogram if and when it is performed subsequently\*.
• Approves collection of relevant additional data for clinical research record if and when these data become available, including results of imaging studies, breast biopsy, and other relevant biomarker data e.g. status of BRCA1, BRCA2, HER2 and receptors (ER+ or ER-) and progesterone (PgR+ or PgR-) \* If a subsequent screening mammogram is reported as abnormal, the subject will be transferred to Group 2 for analysis of data.

You may not qualify if:

• Previous history of an abnormal mammogram, breast disease, or breast biopsy
• Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
• Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
• Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
• General anesthesia during the 10-day period prior to breath collection.
• Group 2: Abnormal screening mammogram
• Female aged 18 years or older
• Understands the study, and is willing to give written informed consent to participate
• Abnormal screening mammogram during preceding six months (BIRADS 3-6)
• Approves collection of relevant additional data for clinical research record if and when it becomes available, including results of imaging studies, biopsy results, and other relevant biomarker data e.g. status of BRCA1, BRCA2, HER2 and receptors (ER+ or ER-) and progesterone (PgR+ or PgR-)
• Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
• Previous history of breast biopsy
• Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
• Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
• General anesthesia during the 10-day period prior to breath collection. -

Sponsors & Collaborators

• Menssana Research, Inc.: lead
• Mount Vernon Cancer Centre: collaborator
• Zuyderland Medical Centre: collaborator
• University of Erlangen-Nürnberg: collaborator

Study Sites (3)

University of Erlangen

Erlangen, Germany

Location

Zuyderland Medical Center

Heerlen, Netherlands

Location

Frimley Health NHS Foundation Trust

Middlesex, HA6 2RN, United Kingdom

Location

Related Publications (37)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alexandra Tenovici

  Frimley Health NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Marc Lobbes, MD

  Zuyderland Medical Center

  PRINCIPAL INVESTIGATOR

• Peter Fasching, MD

  University of Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Phillips, MD

CONTACT

9732649825; mphillips@menssanaresearch.com

Jonah Phillips, MBA

CONTACT

2012406676; jphillips@menssanaresearch.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 16, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

GB (1); NL (1); DE (1)