Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood and Primary Tumor in HNSCC/NSCLC/Melanoma

NCT04490564 | Completed

• 1 other identifier: CBS-PD-L1a
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 6

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 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

Head and Neck Squamous Cell Carcinoma; Melanoma; Non Small Cell Lung Cancer

Keywords

Liquid biopsy; CTC; PD-L1

Outcome Measures

Primary Outcomes (1)

• Clinical performance of PD-L1 kit in CTCs of peripheral blood and tumor tissue samples

  The performance of PD-L1 kit at baseline in CTCs (using IF as reference method) and tumor tissue samples (using IHC as reference method) will be assessed via Sensitivity, Specificity, Positive and Negative Predictive Values, Positive and Negative Likelihood Ratios, Accuracy and Diagnostic Odds Ratio.

  12 months

Secondary Outcomes (1)

• To study correlations between PD-L1 expression in serial liquid samples with patients' responsiveness to therapy.

  18 months

Other Outcomes (2)

• To study mutation status of BRAF gene in tumor tissue samples and blood samples (CTC, plasma ctDNA) of metastatic melanoma patients

  18 months

• To study the presence of biomarkers in tumor tissue and blood liquid biopsy samples (at baseline).

  18 months

Study Arms (2)

HNSCC, NSCLC, melanoma Patients

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.

Diagnostic Test: PD-L1 Kit

Healthy volunteers

In case of healhty volunteers, only peripheral blood samples will be collected.

Diagnostic Test: PD-L1 Kit

Interventions

PD-L1 Kit DIAGNOSTIC_TEST

Clinical performance of PD-L1 kit in CTCs of peripheral blood and tumor tissue samples

HNSCC, NSCLC, melanoma Patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

155 subjects as follows: 25 patients with metastatic/recurrent HNSCC 120 patients with metastatic NSCLC 10 patients with metastatic melanoma 30 healthy subjects

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmassist Ltd: lead
• University of Athens: collaborator

Study Sites (6)

University General Hospital of Alexandroupoli

Alexandroupoli, Alexandroupolis, 68100, Greece

Location

Sotiria Thoracic Diseases Hospital of Athens

Athens, Attica, 11527, Greece

Location

Aretaieio University Hospital of Athens

Athens, Attica, 11528, Greece

Location

University General Hospital of Athens Attikon

Athens, Attica, 124 62, Greece

Location

Metropolital Hospital

Piraeus, Piraeus, 18547, Greece

Location

Bioclinic

Thessaloniki, Thessaloniki, 546 22, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

CTCs of peripheral blood and primary tumor tissue (FFPEs) samples.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung; Melanoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: July 29, 2020
• Study Start: June 25, 2019
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

GR (6)