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
| Sponsors |
Lead Sponsor: University Hospital, Clermont-Ferrand |
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| Source | 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. |
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| Overall Status | Recruiting | ||||||||||||||||||||||||||||||||||||
| Start Date | 2022-02-10 | ||||||||||||||||||||||||||||||||||||
| Completion Date | 2024-02-01 | ||||||||||||||||||||||||||||||||||||
| Primary Completion Date | 2024-02-01 | ||||||||||||||||||||||||||||||||||||
| Phase | N/A | ||||||||||||||||||||||||||||||||||||
| Study Type | Interventional | ||||||||||||||||||||||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 100 |
| Condition | |
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| Intervention |
Intervention Type: Other Intervention Name: Blood sample Description: 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). Arm Group Label: Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor Other Name: Archived tumor sample |
| Eligibility |
Criteria:
Inclusion Criteria: - 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. Exclusion Criteria: - 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 Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
| Overall Official |
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| Overall Contact |
Last Name: Lise LACLAUTRE Phone: +33473754963 Email: [email protected] |
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| Location |
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| Location Countries |
France |
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| Verification Date |
2022-01-01 |
| Responsible Party |
Type: Sponsor |
| Keywords | |
| Has Expanded Access | No |
| Condition Browse | |
| Number Of Arms | 1 |
| Arm Group |
Label: Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor Type: Other Description: 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. |
| Acronym | Onco-PDL1s/B2M |
| Study Design Info |
Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: metastatic solid tumor Primary Purpose: Other Masking: None (Open Label) |
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