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

Not Applicable

Active, not recruiting

• Conditions: Cancer
• Interventions: Drug: Immunotherapeutic Agent; Drug: Molecular Target

• Registration Number: NCT03835520
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-11
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2028-05
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMMUNOTHERAPY	Immunotherapeutic Agent	Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
MOLECULAR TARGETED THERAPIES	Molecular Target	Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium