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

Melanoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04490564
• Other study ID #: CBS-PD-L1a
• Status: Active, not recruiting
• Start date: June 25, 2019
• Est. completion date: June 25, 2023

Study information

• Verified date: March 2023
• Source: Pharmassist Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Study procedure:

1. Initial Visit (V0-Baseline): For the purposes of the study the following information will be collected: the demographics, medical and social history, the characteristics of the disease (stage, molecular characterization e.t.c) and the treatment regimen that is followed. As part of the visit, 20 mL of peripheral blood will be drawn prior to their treatment according to physician's suggestion as per common clinical practice. Blood samples will be then sent to ACTC laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Primary tumor tissue samples will be also collected.

2. Follow-up visit (V1): All patients will provide a 10 mL peripheral blood sample during their planned visit at the end of a series of immunotherapy cycles as per clinical practice and physician's judgment. More specifically:

For HNSCC/NSCLC: at the end of four (4) treatment cycles with nivolumab (2 months) or at the end of three (3) treatment cycles with pembrolizumab (2 months) or on disease progress (PD) For melanoma: at 6 months after treatment initiation (antiPD-1) Blood samples will be then sent to laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Clinical response (CR, PR, SD, PD) will be also documented.

3. Follow-up visit (V2): All patients will provide a 10 mL peripheral blood sample on progress of the disease or at the end of the observation period, as diagnosed during their planned visit as per clinical practice and physician's judgment. Blood samples will be then sent to laboratory

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 185
• Est. completion date: June 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Squamous Cell Carcinoma
• Melanoma
• Non Small Cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupoli	Alexandroupolis
Greece	Aretaieio University Hospital of Athens	Athens	Attica
Greece	Sotiria Thoracic Diseases Hospital of Athens	Athens	Attica
Greece	University General Hospital of Athens Attikon	Athens	Attika
Greece	Metropolital Hospital	Piraeus
Greece	Bioclinic	Thessaloníki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Pharmassist Ltd	University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To study mutation status of BRAF gene in tumor tissue samples and blood samples (CTC, plasma ctDNA) of metastatic melanoma patients	Mutation profile of BRAF in CTCs, plasma-ctDNA and tumor tissues of metastatic melanoma patients will be evaluated using PCR-molecular assays	18 months
Other	To study the presence of biomarkers in tumor tissue and blood liquid biopsy samples (at baseline).	Molecular profile of cancer biomarkers in tumor tissue and peripheral blood samples will be evaluated using PCR-molecular assays	18 months
Primary	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	To study correlations between PD-L1 expression in serial liquid samples with patients' responsiveness to therapy.	Clinical response to the selected treatment (CR, PR, SD, PD); Survival status	18 months