Cancer
Conditions
Keywords
Immunotherapy, Molecular Targeted Therapies, Tumor Biopsy, Plasma Samples
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.
Interventions
Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
DRUGMolecular 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.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking and allocation tbc
Intervention model description
The trial will include patients with any type of cancer treated with one of the following regimens after signing of the patient's informed consent: * I: Molecular targeted agent * II: Immunotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of treatment against Cancer | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Objective tumor response will be measured according to the RECIST 1.1 criteria. |
| Overall survival (OS) | 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 | 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. |
Countries
Belgium
Outcome results
None listed