Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood and Primary Tumor … (NCT04490564) | Clinical Trial Compass
CompletedNot Applicable
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood and Primary Tumor in HNSCC/NSCLC/Melanoma
Greece135 participantsStarted 2019-06-25
Plain-language summary
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female aged ≥ 18 years of age.
✓. Patients with a diagnosis of
✓. recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), who are going to receive PD-1 inhibitor nivolumab OR
✓. metastatic Non-Small Cell Lung Cancer (NSCLC), who are going to receive PD-1 inhibitor, e.g. nivolumab, pembrolizumab,OR
✓. metastatic melanoma, who are going to receive to receive PD-1 inhibitor, e.g. nivolumab, pembrolizumab.
✓. Available tumor tissue sample for immunohistochemical and molecular analysis.
✓. Life expectancy ≥ 4 months.
✓. Signed informed consent form.
Exclusion criteria
✕. Male or female younger than 18 years old.
✕. History of another malignancy within 3 years or current 2nd primary malignancy.
What they're measuring
1
Clinical performance of PD-L1 kit in CTCs of peripheral blood and tumor tissue samples