Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03835520

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunotherapeutic Agent

Drug

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.

Molecular Target

Drug

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.

Primary outcomes

  1. 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

  1. Overall survival (OS)

    Time frame: 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.

  2. Progression free survival

    Time frame: 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.

  3. Objective tumor response

    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

    Objective tumor response will be measured according to the RECIST 1.1 criteria.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: Plasma-Target

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Feb 8, 2019
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.