Exploratory Interventional Study of Prognostic Serum Biomarkers of Cancer Progression

NCT05426317 | Unknown

• 2 other identifiers: RBHP 2021 DOUGE2021-A02495-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Non Small Cell Lung Cancer; Renal Cancer

Keywords

imunotherapy; biomarkers; prognostic

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (17)

• progression-free survival

  6 month after inclusion

• progression-free survival

  12 month after inclusion

• overall survival

  6 month after inclusion

• overall survival

  12 month after inclusion

• level of tumor PDL1

  CYCLE 1 DAY 1 (each cycle is 21 days)

Study Arms (1)

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

OTHER

* 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.

Other: Blood sample

Interventions

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).

Also known as: Archived tumor sample

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Kidney Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Aurore DOUGE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: metastatic solid tumor

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: June 22, 2022
• Study Start: February 10, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: June 22, 2022

Record last verified: 2022-01

Locations

FR (1)