Breath Test to Predict Breast Cancer and Outcome of Mammography

February 12, 2021 updated by: Menssana Research, Inc.
To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

We will determine the accuracy of volatile organic compounds (VOCs) in the breath as predictors of risk of breast cancer and an abnormal mammogram. Breath samples will be collected using an ultra-clean collection bag and analyzed with gas chromatography surface acoustic wave detection (GC SAW)

The study will be performed in two phases:

Phase 1: Model-building phase (cross-sectional study): Breath VOCs will be employed to construct multivariate algorithms that distinguish between normal women and those with breast cancer and abnormal screening mammograms.

Phase 2: Model-testing phase (cross-sectional study): The predictive accuracy of these algorithms will be tested to predict outcomes in normal women and those with breast cancer and abnormal screening mammograms.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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)

Description

Group 1: Normal screening mammogram

Inclusion Criteria:

  1. Female aged 18 years or older
  2. Understands the study, and is willing to give written informed consent to participate
  3. If a screening mammogram was performed during the preceding six month period, then the results were reported as normal (BIRADS 1 or 2)
  4. 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*.
  5. 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.

Exclusion Criteria:

  1. Previous history of an abnormal mammogram, breast disease, or breast biopsy
  2. Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
  3. Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
  4. Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
  5. General anesthesia during the 10-day period prior to breath collection.

Group 2: Abnormal screening mammogram

Inclusion Criteria:

Female aged 18 years or older

  1. Understands the study, and is willing to give written informed consent to participate
  2. Abnormal screening mammogram during preceding six months (BIRADS 3-6)
  3. 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-)

Exclusion criteria:

  1. Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
  2. Previous history of breast biopsy
  3. Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
  4. Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
  5. General anesthesia during the 10-day period prior to breath collection. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Normal screening mammogram (BIRADS 1 or 2)
Device: BreathX test for breath VOCs
Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.
Group 2
Abnormal screening mammogram (BIRADS 3 to 6)
Device: BreathX test for breath VOCs
Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BREATH TEST TO PREDICT BREAST CANCER
Time Frame: 2 years
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
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menssana Research, Inc.

Collaborators

University of Erlangen-Nürnberg
Zuyderland Medical Centre
Mount Vernon Cancer Centre

Investigators

  • Principal Investigator: Alexandra Tenovici, Frimley Health NHS Foundation Trust
  • Principal Investigator: Marc Lobbes, MD, Zuyderland Medical Center
  • Principal Investigator: Peter Fasching, MD, University of Erlangen-Nürnberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2020 UK01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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