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JOURNAL ONKOLOGIE – STUDIE

Breath Test to Predict Breast Cancer and Outcome of Mammography

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NCT-Nummer:
NCT04755829

Studienbeginn:
März 2021

Letztes Update:
16.02.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Menssana Research, Inc.

Collaborator:
Mount Vernon Cancer Centre, Zuyderland Medical Centre, University of Erlangen-Nürnberg,

Studienleiter

Alexandra Tenovici
Principal Investigator
FRIMLEY HEALTH NHS FOUNDATION TRUST
Marc Lobbes, MD
Principal Investigator
Zuyderland Medical Center
Peter Fasching, MD
Principal Investigator
University of Erlangen-Nürnberg

Kontakt

Studienlocations
(3 von 3)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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. -

Studien-Rationale

Primary outcome:

1. 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. 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

Studien-Arme

  • Group 1
    Normal screening mammogram (BIRADS 1 or 2)
  • Group 2
    Abnormal screening mammogram (BIRADS 3 to 6)

Geprüfte Regime

  • BreathX test for breath VOCs:
    Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.

Quelle: ClinicalTrials.gov


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