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The value of single nucleotide polymorphisms in genes of serum markers in breast cancer diagnostics

Completed
Conditions
breast cancer
mammacarcinoma
10006291
Registration Number
NL-OMON32263
Lead Sponsor
Sint Antonius Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
858
Inclusion Criteria

Women older than 18 years with a breast lump

Exclusion Criteria

Patients are excluded if:
· they are male
· they are younger than 18 years
· they are unable to give informed consent due to other circumstances (delirium at admission, severe psychiatric disease)

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>· CA15-3, CEA, Her-2 and YKL-40 levels and its SNPs (measured in serum and<br /><br>cells collected from blood using immunochemical and molecular methods).<br /><br><br /><br>· To investigate whether the MUC1 568 A/G polymorphism in combination with<br /><br>CA15-3, the CHI3L1-329 G/A polymorphism in combination with YKL-40 and the<br /><br>Her2 I655V polymorphism in combination with Her-2 levels can increase its roles<br /><br>in primary screening and (early) detection of renewed breast cancer activity<br /><br>in the follow-up after curative treatment.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>· To investigate differences in genotype and serum marker levels between<br /><br>premenopausal and postmenopausal women<br /><br><br /><br>· To investigate whether (combinations of) SNPs are associated with prognostic<br /><br>factors like tumour size, tumour grade and nodal involvement<br /><br><br /><br>· To explore serum markers and its SNPs appearing in scientific literature as<br /><br>promising diagnostic tests during the course of the study (addendum needed)<br /><br><br /><br>· To establish functional consequences of SNPs of genes of serum marker in<br /><br>relation with tumour specific therapy</p><br>
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