The study objectives are:1. Getting insight into the biological origin of the typical serum protein profile in breast cancer by comparing the protein profiles in breast tissue of benign breast disease patients and primary breast cancer patients with…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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c. intra-individual differences in protein profiles in serum withdrawn before,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 outcome
Not applicable.
Background summary
Breast cancer accounts for one third of all new cancer cases among women in The
Netherlands. About 36% of these women will ultimately die because of this
disease. Detecting early stage cancer by pre-symptomatic screening can greatly
reduce breast cancer-related mortality. Currently used methods (mammography,
CA15.3), however, still lack adequate sensitivity and specificity. In a pilot
study conducted earlier, we identified several serum biomarkers for breast
cancer, using the Surface Enhanced Laser Desorption Ionisation Time-of-Flight
Mass Spectrometry (SELDI-TOF MS) technique. Knowing the origin of these
biomarkers will greatly aid in understanding the pathogenesis of breast cancer.
Both invasive cancer and premalignant lesions (benign breast diseases) have
been demonstrated to share several genetic alterations. We therefore
hypothesize that protein expression, as a genome derivative, will to some
extend be homologous in both premalignant and malignant tissue. Possibly,
benign breast diseases share a certain serum and tissue protein expression
profile with invasive breast carcinoma. When structurally identified, these
specific proteins can provide further insight into the molecular development of
breast cancer.
Study objective
The study objectives are:
1. Getting insight into the biological origin of the typical serum protein
profile in breast cancer by comparing the protein profiles in breast tissue of
benign breast disease patients and primary breast cancer patients with the
corresponding serum protein profiles.
2. Investigating the presence of homologous proteins, or specific,
differentially expressed proteins in:
a. serum of benign breast disease and breast cancer patients, and
b. normal, benign diseased, and cancerous tissue,
to gain more insight into the molecular development of breast cancer.
3. Investigating the effect of surgery on the serum protein profile of benign
breast disease patients and primary breast cancer patients. This might also
give us more insight into the origin and the conditions under which the
discovered protein profiles emerge.
4. Determination of a possible correlation between biomarkers and co-morbidity,
co-medication and patient-depending variables such as age, to determine
appropriate stratification or adjustment for the analysis.
Study design
Prospective follow-up study.
Study burden and risks
All serum samples will be obtained along with samples for routine clinical
chemical laboratory assays. Tissue specimens of breast tumours, benign breast
diseases, or normal breast tissue will be obtained during surgery (e.g.
lumpectomy, mastectomy of breast reduction surgery). Since withdrawal of serum
and tissue is performed within the compass of treatment, no additional
inconvenience is posed on these patients.
Louwesweg 6
1066 EC Amsterdam
Nederland
Louwesweg 6
1066 EC Amsterdam
Nederland
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14905.048.06 |