Clinical trial · Observational
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood and Primary Tumor in HNSCC/NSCLC/Melanoma
A Clinical Performance Study to Validate the Use of Novel Molecular Diagnostic Assays for the Detection of Cancer Biomarkers in Peripheral Blood and Primary Tumor Tissue of Patients With Recurrent/Metastatic HNSCC, NSCLC or Melanoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-L1 Kit | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HNSCC, NSCLC, melanoma Patients
- description
- The study population are subjects with a confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), who are going to receive PD-1 inhibitor nivolumab or ii) metastatic Non-Small Cell Lung Cancer (NSCLC), who are going to receive PD-1 inhibitor, e.g. nivolumab, pembrolizumab or iii) metastatic melanoma, who are going to receive PD-1 inhibitor, e.g. nivolumab, embrolizumab. The selected inclusion/exclusion criteria have been set to include in the performance study appropriate population of interest, as broad as possible, but to exclude these subjects that have another current malignancy or any history of recent malignancy within 3 years.
- interventionNames
- Diagnostic Test: PD-L1 Kit
- label
- Healthy volunteers
- description
- In case of healhty volunteers, only peripheral blood samples will be collected.
- interventionNames
- Diagnostic Test: PD-L1 Kit
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female aged ≥ 18 years of age. 2. Patients with a diagnosis of 1. recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), who are going to receive PD-1 inhibitor nivolumab OR 2. metastatic Non-Small Cell Lung Cancer (NSCLC), who are going to receive PD-1 inhibitor, e.g. nivolumab, pembrolizumab,OR 3. metastatic melanoma, who are going to receive to receive PD-1 inhibitor, e.g. nivolumab, pembrolizumab. 3. Available tumor tissue sample for immunohistochemical and molecular analysis. 4. Life expectancy ≥ 4 months. 5. Signed informed consent form. Exclusion Criteria: 1. Male or female younger than 18 years old. 2. History of another malignancy within 3 years or current 2nd primary malignancy. 3. Patients that have not signed the informed consent.
References
Publications (1)
- DERIVEDNtzifa A, Themistokli E, Strati A, Zavridou M, Tsaroucha E, Sfika A, Psyrri A, Balgouranidou I, Kotsakis A, Georgoulias V, Lianidou E. AXL-mRNA Overexpression in Size-Based Enriched Circulating Tumor Cells as a Potential Biomarker for Anti-AXL Targeted Therapies in Non-Small-Cell Lung Cancer. Cancers (Basel). 2026 May 28;18(11):1759. doi: 10.3390/cancers18111759. PMID 42279342