Microsampling Approach for Monitoring of Kinase Inhibitor Targeted Therapies

NCT ID: NCT05598788

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-03

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Blood Concentrations of Nine Anti-cancer Drugs : Axitinib, Olaparib, regorafénib, Cabozantinib, Niraparib, Talazoparib, Palbociclib, Abemaciclib, Tucatinib

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Measurement of drug concentrations

Measurement of anti-cancer drug concentrations using volumetric absorptive micro-sampling (VAMS) and venous blood sample

Intervention Type OTHER

Other Intervention Names

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Micro-sampling

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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VERDIER Marie-Clemence

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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Centre Eugène Marquis Unicancer

Rennes, , France

Site Status RECRUITING

Rennes University Hospital

Rennes, , France

Site Status RECRUITING

Institut de cancérologie Strasbourg Europe

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Ferragu Cécile

Role: CONTACT

0299282555

Facility Contacts

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Le Du Fanny

Role: primary

LIEVRE Astrid

Role: primary

BARTHELEMY Philippe

Role: primary

Other Identifiers

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35RC22_8962_MISTIK

Identifier Type: -

Identifier Source: org_study_id

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