Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression
- Conditions
- MelanomaNon Small Cell Lung CancerRenal Cancer
- Interventions
- Other: Blood sample
- Registration Number
- NCT05426317
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Adult patient, male or female, with metastatic cancer of the non-small cell, renal or malignant melanoma type, eligible for treatment with a first-line immune checkpoint inhibitor (immunotherapy alone or in combination with another immunotherapy, chemotherapy or targeted therapy).
- Affiliation to a Social Security organization
- Able to give informed consent to participate in research.
- Pregnant women
- Patient under guardianship, curatorship or legal protection
- Patient unable to understand the protocol (language barrier, cognitive difficulties)
- Patient with another active cancer
- Patient with creatinine clearance <60 mL / min
- Patient participating in a therapeutic clinical trial
- Refusal of participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor Blood sample * The determinations of soluble PDL1 and serum B2M will be taken by blood sample at diagnosis and then every 3 months for 1 year, during a consultation or treatment in an outpatient hospital. * The measurement of the tumor PDL1 level at diagnosis will be carried out by immunohistochemistry in the anatomopathology department of Clermont Ferrand University Hospital on the tumor sample that allowed the diagnosis, which does not add an additional sample for the patient. * Clinical and imaging examinations will be those conventionally carried out in the context of patient monitoring, the data will only be recorded in the patients' medical files.
- Primary Outcome Measures
Name Time Method determination of soluble PDL1 the day of the start of immunotherapy ng/mL
determination of soluble B2M the day of the start of immunotherapy mg/L
Imaging tumor response 12 month after inclusion RECIST1.1 criteria
- Secondary Outcome Measures
Name Time Method progression-free survival 12 month after inclusion RECIST1.1 criteria
determination of soluble B2M 12 month after inclusion mg/L
adverse events 12 month after inclusion CTCAE
overall survival 12 month after inclusion Alive or Dead
level of tumor PDL1 CYCLE 1 DAY 1 (each cycle is 21 days) determination of soluble PDL1 12 month after inclusion ng/mL
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France