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Validation of circulating tumor cells (CTC) detection techniques in patients with advanced solid tumors

Conditions
Advanced cancer
10027655
Registration Number
NL-OMON33920
Lead Sponsor
Antoni van Leeuwenhoek Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

Patients who are treated for advanced solid tumors;
Age of 18 years or older;
Able and willing to give written informed consent;
Able and willing to undergo veni-puncture;
Life expectancy of 3 months or more;
WHO performance status of 0, 1 or 2;

Exclusion Criteria

Any condition that may interfere with the study protocol

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary objective<br /><br>To optimize CTC detection assay sensitivity and specificity in different types<br /><br>of advanced solid tumors by comparison of enrichment techniques and expression<br /><br>level of a panel of selected marker genes.<br /><br><br /><br>Amendment:<br /><br>To compare CTC detection results of the FAST cytometry method to the qRT-PCR<br /><br>method.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary objectives<br /><br>To determine intra-patient variation of CTC detection assay outcome.<br /><br>To assess inter-patient variation in CTC detection assay outcome.<br /><br>To determine which CTC detection assay is best suitable in the population of<br /><br>patients that participate in clinical trials.</p><br>
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