Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02495-36 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor | Other |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| determination of soluble PDL1 | ng/mL | the day of the start of immunotherapy |
| determination of soluble B2M | mg/L | the day of the start of immunotherapy |
| Imaging tumor response | RECIST1.1 criteria | 3 month after inclusion |
| Imaging tumor response | RECIST1.1 criteria | 6 month after inclusion |
| Imaging tumor response | RECIST1.1 criteria | 9 month after inclusion |
| Imaging tumor response | RECIST1.1 criteria | 12 month after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | RECIST1.1 criteria | 6 month after inclusion |
| progression-free survival | RECIST1.1 criteria | 12 month after inclusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | +33473754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Aurore DOUGE | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
metastatic solid tumor
Not provided
Not provided
Not provided
Not provided
|
|
| overall survival | Alive or Dead | 6 month after inclusion |
| overall survival | Alive or Dead | 12 month after inclusion |
| level of tumor PDL1 | CYCLE 1 DAY 1 (each cycle is 21 days) |
| determination of soluble PDL1 | ng/mL | 3 month after inclusion |
| determination of soluble PDL1 | ng/mL | 6 month after inclusion |
| determination of soluble PDL1 | ng/mL | 9 month after inclusion |
| determination of soluble PDL1 | ng/mL | 12 month after inclusion |
| determination of soluble B2M | mg/L | 3 month after inclusion |
| determination of soluble B2M | mg/L | 6 month after inclusion |
| determination of soluble B2M | mg/L | 9 month after inclusion |
| determination of soluble B2M | mg/L | 12 month after inclusion |
| adverse events | CTCAE | 3 month after inclusion |
| adverse events | CTCAE | 6 month after inclusion |
| adverse events | CTCAE | 9 month after inclusion |
| adverse events | CTCAE | 12 month after inclusion |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |