NCT05426317

Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression

Study of the Relationship Between the Blood Levels of Soluble PDL1 and β2-microglobulin, and the Clinical Course of a Metastatic Solid Tumor Treated With a First-line Therapeutic of Checkpoint Immune Inhibitor

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Exploratory interventional study of prognostic serum biomarkers of cancer progression. Study of the relationship between the blood levels of soluble PDL1 and β2-microglobulin, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic of checkpoint immune inhibitor.

Detailed description

Primary objective To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured at the diagnostic stage, and the clinical course of a metastatic solid tumor (non-small cell lung cancer, kidney cancer, or melanoma) treated with a 1st line therapeutic immune checkpoint inhibitor. The secondary objectives are: * To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured during treatment, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic immune checkpoint inhibitor. * To study the correlation between the soluble PDL1 level and the tumor PDL1 level. * To study the correlation between the blood levels of soluble PDL1 and β2-microglobulin. * To study the relationship between the blood levels of soluble PDL1 and β2-microglobulin measured during the treatment, and the tolerance of treatment with immune checkpoint inhibitor in 1st line therapy.

Conditions

• Melanoma
• Non Small Cell Lung Cancer
• Renal Cancer

Interventions

Type	Name	Description
OTHER	Blood sample	This study only involves the patient taking 5 additional blood tests (peripheral venipuncture) compared to his usual care, which will be taken when he comes to the hospital. Each sample only requires a blood volume of 5mL (one tube), or a total blood volume of 25mL for the study (one blood test every 3 months for one year).

Timeline

• Start date: 2022-02-10
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-06-22
• Last updated: 2022-06-22

Locations

1 site across 1 country: France