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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Immunotherapeutic Agent
* Drug: Molecular Target


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOLECULAR TARGETED THERAPIES<br>Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions. | Drug: Molecular Target<br>* 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.<br>|
| Experimental: IMMUNOTHERAPY<br>Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. | Drug: Immunotherapeutic Agent<br>* Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of treatment against Cancer | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | 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. | From date of randomization until the date of first documented progression assessed up to 120 months | 
| Progression free survival | 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. | From date of randomization until the date of first documented progression , assessed up to 120 months | 
| Objective tumor response | Objective tumor response will be measured according to the RECIST 1.1 criteria. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, Molecular Targeted Therapies, Tumor Biopsy, Plasma Samples