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

Biomarker detection for benign breast diseases and primary breast cancer by serum and tissue protein profiling. - Breast Cancer Proteomics study (BCP study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30316

Enrollment

380

Registered

2006-11-10

Start date

2006-11-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

benign breast diseases breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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 c. intra-individual differences in protein profiles in serum withdrawn before, directly after and one month after surgery of patients with benign breast disease or breast cancer.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

Measure

Time frame

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 c. intra-individual differences in protein profiles in serum withdrawn before, directly after and one month after surgery of patients with benign breast disease or breast cancer.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results