Biomarker detection for benign breast diseases and primary breast cancer by serum and tissue protein profiling.

Conditions: benign breast diseases
breast cancer
10006291

Registration Number: NL-OMON30316

Lead Sponsor: Slotervaartziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 380

Inclusion Criteria

1. Female patients diagnosed with benign breast disease or primary breast cancer (that will be treated surgically) by breast biopsy at the Department of Surgery of the Slotervaart Hospital in Amsterdam.
2. Female patients diagnosed with benign breast disease and treated surgically the Department of Surgery of the Slotervaart Hospital in Amsterdam.
3. Female patients undergoing breast reduction surgery at the Department of Plastic Surgery of the Slotervaart Hospital in Amsterdam.
4. Age > 18yrs.
5. Able and willing to undergo blood and tissue sampling for protein analysis.

Exclusion Criteria

1. Known history of (treated) malignancies.
2. Incapacity of participant to give written informed consent.
3. Patients not able to undergo blood and tissue sampling for protein analysis.
4. Any psychological, familial, sociological or geographical condition that may potentially interfere with compliance to the study protocol.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study outcomes are:<br /><br>a. differences in protein profiles between serum samples and tissue specimens<br /><br>of patients with benign breast disease and breast cancer patients,<br /><br>b. differences in protein profiles between serum samples of benign breast<br /><br>disease and breast cancer patients, and between specimens of normal, benign and<br /><br>tumourous tissue.<br /><br>c. intra-individual differences in protein profiles in serum withdrawn before,<br /><br>directly after and one month after surgery of patients with benign breast<br /><br>disease or breast cancer. </p><br>

Secondary Outcome Measures