To collect repeated samples of blood from patients (starting) on TKI, for liquid mutation testing to assess the clinical relevant cutoff value, and pharmacokinetic analysis.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(Resistance) mutation plasma levels, pharmacokinetics of TKI (through levels)
during treatment and at progression.
Secondary outcome
Primary mutation levels, time to progression, correlation to (re)biopsy
specimen results performed for standard-of-care. Furthermore TKI, smoking
status, BMI.
Background summary
In pulmonary oncology patients with oncogenic driver mutations, TKI are used as
targeted therapy, but eventually acquired resistance will take place. Standard
of care is to use invasive rebiopsy to diagnose resistance mechanisms, while
new methods of testing on circulating tumor material could detect the mutations
of interest in plasma. Possibly this means that detection can take place even
before clinical progression is seen, without need of an invasive procedure.
Pharmacokinetic differences may influence the development of acquired
resistance.
Study objective
To collect repeated samples of blood from patients (starting) on TKI, for
liquid mutation testing to assess the clinical relevant cutoff value, and
pharmacokinetic analysis.
Study design
Observational study with extra blood sampling at already planned moments of
blood withdrawal.
Study burden and risks
The extra risk of taking three additional tubes during blood withdrawal is
regarded negligible.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years
• Able to understand the written informed and able to give informed consent
• Locally advanced or metastatic lung cancer with oncogenic driver mutation
• Treatment with TKI according to standard of care
Exclusion criteria
• Unable to draw blood for study purposes
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58664.078.16 |