Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Molecular Target
- Conditions
- Cancer
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- efficacy of treatment against Cancer
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Molecular Target
IMMUNOTHERAPY
Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
Intervention: Immunotherapeutic Agent
Outcomes
Primary Outcomes
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 Outcomes
- Overall survival (OS)(From date of randomization until the date of first documented progression assessed up to 120 months)
- Progression free survival(From date of randomization until the date of first documented progression , assessed up to 120 months)
- Objective tumor response(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)