Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression

NCT ID: NCT05426317

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2024-02-29

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.

Conditions

Melanoma; Non Small Cell Lung Cancer; Renal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Metastatic solid tumor treated with first line therapeutic of Immune Checkpoint Inhibitor

• 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.

Group Type: OTHER

Blood sample

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurore DOUGE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Other Identifiers

2021-A02495-36

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2021 DOUGE

Identifier Type: -

Identifier Source: org_study_id