Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy

Overview

The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy. Immunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions. With the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2028

Interventions

  • Drug: Immunotherapeutic Agent
    • Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
  • Drug: Molecular Target
    • Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer’s instructions.

Arms, Groups and Cohorts

  • Experimental: MOLECULAR TARGETED THERAPIES
    • Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer’s instructions.
  • Experimental: IMMUNOTHERAPY
    • Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.

Clinical Trial Outcome Measures

Primary Measures

  • efficacy of treatment against Cancer
    • Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
    • Efficacy will be determined in terms of overall responses according to standard practice by the local investigator. Disease and response assessments are defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Measures

  • Overall survival (OS)
    • Time Frame: From date of randomization until the date of first documented progression assessed up to 120 months
    • Overall survival is defined as the time from the date of inclusion to the date of death from any cause or to the date of last follow-up (in exceptional cases where it is impossible to document the date of death). Every effort should be made to document the cause of death.
  • Progression free survival
    • Time Frame: From date of randomization until the date of first documented progression , assessed up to 120 months
    • Progression free survival (PFS) will be measured from the date of inclusion to the date of progression or death, whatever the cause. Progression will be defined according to the RECIST criteria.
  • Objective tumor response
    • Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
    • Objective tumor response will be measured according to the RECIST 1.1 criteria.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with cancer treated with one of the following regimens: Molecular targeted agents or Immunotherapy – Paraffin-embedded tumor tissue available for immunohistochemistry and/or DNA extraction. – Patient able to give written informed consent. Exclusion Criteria:

  • Patients with cancer treated with other regimen

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • Provider of Information About this Clinical Study
    • Sponsor

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