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MISTIK: Microsampling Approach for Monitoring of Kinase Inhibitor Targeted Therapies

Sponsor
Rennes University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05598788
Collaborator
(none)
360
Enrollment
3
Locations
13
Anticipated Duration (Months)
120
Patients Per Site
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Measurement of drug concentrations

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
360 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Development of a Microsampling Approach for Personalized Monitoring of Kinase Inhibitor Targeted Therapies
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Comparison of venous blood vs VAMS concentrations [1 day]

    Comparison of drug concentrations measured from the venous blood samples with concentrations measured from VAMS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Eugène Marquis Unicancer Rennes France 35000
2 Rennes University Hospital Rennes France 35000
3 Institut de cancérologie Strasbourg Europe Strasbourg France 67033

Sponsors and Collaborators

  • Rennes University Hospital

Investigators

  • Principal Investigator: VERDIER Marie-Clemence, Rennes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT05598788
Other Study ID Numbers:
  • 35RC22_8962_MISTIK
First Posted:
Oct 28, 2022
Last Update Posted:
Nov 8, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rennes University Hospital
ORAL CHEMOTHERAPIES
AT HOME THERAPEUTIC DRUG MONITORING
MICROSAMPLING STRATEGY
CONCENTRATION EFFECT RELATIONSHIP
PERSONALIZED MEDICINE

Study Results

No Results Posted as of Nov 8, 2022