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Active, not recruitingNCT03835520Plasma-TargetUpdated Dec 11, 2023

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

An interventional study of Immunotherapeutic Agent and Molecular Target in Cancer, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Cancer

Keywords

  • Immunotherapy
  • Molecular Targeted Therapies
  • Tumor Biopsy
  • Plasma Samples
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In context

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Patients with cancer treated with other regimen
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    MOLECULAR TARGETED THERAPIES

    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

  • Experimental
    IMMUNOTHERAPY

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

    Drug: Immunotherapeutic Agent

Interventions

  • DrugImmunotherapeutic Agent

    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.

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What researchers measure

Primary outcomes

  1. 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.

    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

Secondary outcomes

  1. 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.

    Time frame: From date of randomization until the date of first documented progression assessed up to 120 months

  2. 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.

    Time frame: From date of randomization until the date of first documented progression , assessed up to 120 months

  3. Objective tumor response

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

    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

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Study locations

1 site
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03835520
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Feb 8, 2019
Start date
Jul 11, 2018
Primary completion
May 2028 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Dec 11, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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