Breath test for breast cancer using the BREATHLINK*

Breath test for breast cancer using the BREATHLINK* - Point of care breath test for breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38138

Enrollment

100

Registered

2012-04-04

Start date

2012-09-06

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vrouwen met een normaal mammogram en vrouwen met een afwijkend mammogram gevolgd door biopsie, PA benigne of borstkanker breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group 1 1. Breath sample collected during 7-day period prior to screening mammography. 2. Patient has no prior history of cancer. 3. Patient understands the study and is willing and able to give signed informed consent to participate. 4. Patient agrees to provide the results of their mammogram 5.Female, age >

Exclusion criteria

Exclusion criteria: Group 1 1. Previous history of breast cancer. 2. Previous history of cancer at any other site. 3. Previous history of breast biopsy. 4. Previous history of abnormal mammogram. 5. Previous history of palpable breast mass. Group 2: 1. Previous history of breast cancer. 2. Previous history of cancer at any other site.

Design outcomes

Primary

Measure	Time frame
Targeted outcome: ROC curves for multivariate predictive algorithms that will predict a woman*s membership in one of the following categories: 1. Breast cancer negative 2. Breast cancer positive ROC curves in the breast cancer positive group will be stratified for disease stage with information about the tumors genetic background, with C-statistic, sensitivity, specificity and confidence intervals.	—

Measure

Time frame

Targeted outcome: ROC curves for multivariate predictive algorithms that will predict a woman*s membership in one of the following categories: 1. Breast cancer negative 2. Breast cancer positive ROC curves in the breast cancer positive group will be stratified for disease stage with information about the tumors genetic background, with C-statistic, sensitivity, specificity and confidence intervals.

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Countries

Netherlands

Outcome results