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Trial Title:
Microsampling Approach for Monitoring of Kinase Inhibitor Targeted Therapies
NCT ID:
NCT05598788
Condition:
Blood Concentrations of Nine Anti-cancer Drugs : Axitinib, Olaparib, regorafénib, Cabozantinib, Niraparib, Talazoparib, Palbociclib, Abemaciclib, Tucatinib
Conditions: Keywords:
ORAL CHEMOTHERAPIES
AT HOME THERAPEUTIC DRUG MONITORING
MICROSAMPLING STRATEGY
CONCENTRATION EFFECT RELATIONSHIP
PERSONALIZED MEDICINE
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Measurement of drug concentrations
Description:
Measurement of anti-cancer drug concentrations using volumetric absorptive micro-sampling
(VAMS) and venous blood sample
Other name:
Micro-sampling
Summary:
The MISTIK project aims at clinically validating the technique of oral anticancer drugs
determination by volumetric absorptive micro-sampling and at comparing the results to
measurements performed on venous samples.
Detailed description:
The International recommendations for the validation of DBS-based methods will be applied
(Capiau et al, TDM, 2019) by including 40 patients per molecule of interest. Nine drugs
will be monitored : axitinib, olaparib, regorafénib, cabozantinib, niraparib,
talazoparib, palbociclib, abemaciclib, tucatinib.
Two samples will be collected from each patient, one by venous sampling and the second at
the same time (approximately) using a capillary blood sample derived from a finger prick.
Criteria for eligibility:
Study pop:
Patients treated with one of the 9 drugs concerned by the study : axitinib, olaparib,
regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients treated with one of the 9 drugs concerned by the study : axitinib,
olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib,
abemaciclib, tucatinib
- person who does not object to their participation in the research
Exclusion Criteria:
- Adults subject to legal protection (safeguard of justice, curatorship,
guardianship), persons deprived of their liberty
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Eugène Marquis Unicancer
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Contact:
Last name:
Le Du Fanny
Facility:
Name:
Rennes University Hospital
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Contact:
Last name:
LIEVRE Astrid
Facility:
Name:
Institut de cancérologie Strasbourg Europe
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Recruiting
Contact:
Last name:
BARTHELEMY Philippe
Start date:
March 3, 2023
Completion date:
December 1, 2023
Lead sponsor:
Agency:
Rennes University Hospital
Agency class:
Other
Source:
Rennes University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05598788
