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임상시험 NCT07491380 (TDHOME)은(는) 유방암에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME) 90 오픈 라벨
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임상시험 NCT07491380 (TDHOME)은(는) 유방암에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 5월 15일부터 참여 신청이 가능합니다. 90명의 참여자를 모집할 예정입니다. Institut Curie이(가) 진행하는 이 연구는 2028년 12월 15일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 24일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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...
더 보기공식 제목
Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients
질환명
유방암기타 연구 식별자
- TDHOME
- IC 2025-03
- ID RCB: 2025-A01797-42 (기타 식별자) (Institut Curie)
NCT 번호
실제 연구 시작일
2026-05-15
최신 업데이트 게시
2026-03-24
예상 연구 완료일
2028-12-15
계획된 등록 인원
90
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
Capillary microsampling, therapeutic drug monitoring, ribociclib, abemaciclib, palbociclib, breast cancer, pharmacokinetics, personalized treatment
주요 목적
기타
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Blood 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). |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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 Curie연구 대표 연락처
연락처: Marie-Emmanuelle Legrier, 0033156245649, [email protected]
1 1개국에 임상시험 장소
France
Institut Curie, Saint-Cloud, France, 92210, France
Marie-Emmanuelle Legrier, 연락처, 0033156245649, [email protected]
Michael Bringuier, PH, 책임연구자
Audrey Bellesoeur, PH, 책임연구자