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El ensayo clínico NCT07491380 (TDHOME) para Cáncer de mama está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME) 90 Etiqueta abierta
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El ensayo clínico NCT07491380 (TDHOME) es un estudio intervencionista para Cáncer de mama. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 15 de mayo de 2026 hasta completar 90 participantes. Dirigido por Institut Curie, se espera que finalice el 15 de diciembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 24 de marzo de 2026.
Resumen
This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.
Descripción detallada
Therapeutic drug monitoring (TDM) could serve as a valuable tool to minimize adverse events and maximize the efficacy of treatment in breast cancer patients receiving CDK4/6 inhibitors (ribociclib, abemaciclib, palbociclib). However, current TDM performed via venous blood draws can be inconvenient, especially for repeated sampling.
This study aims to evaluate the reliability of capillary (fingertip) microsampling-wh...
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Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients
Condiciones médicas
Cáncer de mamaOtros ID del estudio
- TDHOME
- IC 2025-03
- ID RCB: 2025-A01797-42 (Otro identificador) (Institut Curie)
Número del NCT
Inicio del estudio (real)
2026-05-15
Última actualización
2026-03-24
Fecha de finalización (estimada)
2028-12-15
Inscripción (prevista)
90
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
Capillary microsampling, therapeutic drug monitoring, ribociclib, abemaciclib, palbociclib, breast cancer, pharmacokinetics, personalized treatment
Objetivo principal
Otros
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalBlood samples collection in breast cancer in patients receiving CDK4/6 inhibitors Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4/6 regimen).
The patients will also complete an acceptability Questionnaire following the samplings. | Capillary samples using the VAMS Mitra device Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4/6 regimen).
* 4 capillary samples (using the VAMS Mitra device) including 2 samples collected by the study nurse then 2 samples collected by the patient.
* 1 venous sample (5 mL heparinized tube). |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling. | The primary objective of the study is therefore to validate the reliability of capillary sampling (using the VAMS Mitra device) as an alternative to venous sampling for TDM of CDK4/6 inhibitors (ribociclib, abemaciclib, or palbociclib) in breast cancer patients. The primary endpoint will be the concordance between drug concentrations obtained from venous and capillary samples, assessed through Bland-Altman analysis. | Day 1 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Intra-patient's variability of the measurements from microsamplings | Reproducibility of capillary microsampling will be evaluated from the four replicate VAMS collections (two patient-collected, two nurse-collected). We will estimate within-patient variability as the coefficient of variation (CV %) across replicates and report duplicate %-difference. | Day 1 |
Acceptability of the device, as assessed by a patient satisfaction questionnaire. | A satisfaction questionnaire for the use of VAMS-type microsampling device will be completed by the patient after the samples collection. Patient acceptability and usability of VAMS will be summarized descriptively with exploratory comparisons by age, sex, and collection setting (clinic vs home where applicable). | Day 1 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Adult patients (≥ 18 years) with breast cancer.
- Patients currently receiving ribociclib, abemaciclib, or palbociclib.
- Patients capable of performing capillary sampling (with or without assistance).
- Patient information and signing of informed consent.
- Patient ability to comply with protocol requirements.
- Patients covered by a health insurance system.
- Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
- Persons deprived of their liberty or under guardianship.
Institut CurieContactos centrales del estudio
Contacto: Marie-Emmanuelle Legrier, 0033156245649, [email protected]
1 Centros del estudio en 1 países
France
Institut Curie, Saint-Cloud, France, 92210, France
Marie-Emmanuelle Legrier, Contacto, 0033156245649, [email protected]
Michael Bringuier, PH, Investigador principal
Audrey Bellesoeur, PH, Investigador principal