Status:
COMPLETED
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood and Primary Tumor in HNSCC/NSCLC/Melanoma
Lead Sponsor:
Pharmassist Ltd
Collaborating Sponsors:
University of Athens
Conditions:
Head and Neck Squamous Cell Carcinoma
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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 constantl...
Detailed Description
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 constantl...
Eligibility Criteria
Inclusion
- 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
- Male or female younger than 18 years old.
- History of another malignancy within 3 years or current 2nd primary malignancy.
- Patients that have not signed the informed consent.
Key Trial Info
Start Date :
June 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04490564
Start Date
June 25 2019
End Date
September 7 2022
Last Update
December 30 2025
Active Locations (6)
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1
University General Hospital of Alexandroupoli
Alexandroupoli, Alexandroupolis, Greece, 68100
2
Sotiria Thoracic Diseases Hospital of Athens
Athens, Attica, Greece, 11527
3
Aretaieio University Hospital of Athens
Athens, Attica, Greece, 11528
4
University General Hospital of Athens Attikon
Athens, Attica, Greece, 124 62