CancerPlasma-TargetNCT03835520
Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy
A study testing Immunotherapeutic Agent and Molecular Target in people with Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Immunotherapeutic Agent and Molecular Target
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Jul 2018to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with cancer treated with other regimen
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer
- Being tested
- Immunotherapeutic Agent, Molecular Target
- Keywords
- Immunotherapy, Molecular Targeted Therapies, Tumor Biopsy, Plasma Samples
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapeutic AgentDrug
Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
Molecular TargetDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MOLECULAR TARGETED THERAPIES | Experimental | Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions. Receives: Drug: Molecular Target |
| IMMUNOTHERAPY | Experimental | Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Receives: Drug: Immunotherapeutic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start11 Jul 2018
- Primary completionMay 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835520
- Sponsor's protocol ID
- UCL-ONCO 2018-02
- Other IDs
- 2018/11JUI/248, B403201836842
- Acronym
- Plasma-Target
- Status last verified
- Dec 2023
- First submitted
- 8 Oct 2018
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy
- ClinicalTrials.gov ID
- NCT03835520
- Acronym / sponsor ID
- Plasma-Target / UCL-ONCO 2018-02
- Conditions
- Cancer
- Keywords
- Immunotherapy, Molecular Targeted Therapies, Tumor Biopsy, Plasma Samples
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| MOLECULAR TARGETED THERAPIES | Experimental | Drug: Molecular TargetImmunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions. |
| IMMUNOTHERAPY | Experimental | Drug: Immunotherapeutic AgentImmunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with cancer treated with other regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunotherapeutic AgentImmunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. | Drug | IMMUNOTHERAPY |
| Molecular TargetTargeted agents 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 TARGETED THERAPIES |
Primary outcome
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.
3 secondary outcomes
Overall survival (OS)
Time frame: From date of randomization until the date of first documented progression assessed up to 120 months
Progression free survival
Time frame: From date of randomization until the date of first documented progression , assessed up to 120 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunotherapeutic Agent and Molecular Target in people with Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.