Breath test for breast cancer using the BREATHLINK*

Completed

Conditions: vrouwen met een normaal mammogram en vrouwen met een afwijkend mammogram gevolgd door biopsie, PA benigne of borstkanker
breast cancer
10006291

Registration Number: NL-OMON38138

Lead Sponsor: Menssana Research inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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 ><= 18 years.
Group 2 A and 2B
1. Breath sample is collected after breast biopsy and before possible initiation of cancer treatment.
2. Patient agrees to provide the results of their mammogram if available.
3. Patient agrees to provide the results of their breast biopsy.
4. Patient understands the study and is willing and able to give signed informed consent to participate.
5. Female, age ><= 18 years.

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures