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

Cancer Clinical Trial

— Plasma-Target  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03835520
• Other study ID #: UCL-ONCO 2018-02
• Secondary ID: 2018/11JUI/248B4
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: May 1, 2028

Study information

• Verified date: December 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 1, 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Immunotherapeutic Agent
Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
• 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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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