- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01555944
Prospective Observational Study in Patients With Metastatic Breast Cancer Treated With Anthracyclines
Screening and Management of Cardiovascular Risk in Belgian Women Aged > or = 65 Years With Metastatic Breast Cancer Before and After Anthracycline Treatment
This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium.
Principal objectives:
- To evaluate the prevalence of cardiovascular risk factors and cardiac function (as routinely evaluated) before treatment with anthracyclines of patients with metastatic breast cancer (MBC) aged > or = 65 years
- To observe the management of cardiovascular risk during and after anthracycline treatment
- To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30)
Secondary objectives:
- To evaluate the efficacy of anthracyclines on progression free survival and tumor response as routinely measured (e.g. recist criteria, tumor markers and other exams)
- To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment.
- To find out how quality of life, e.g. such as described according to EORTC QLQ-C30 criteria or Karnofsky index is achieved in the various patient subgroups
- To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline
- To calculate the cardiovascular risk according to SCORE
연구 개요
상태
정황
상세 설명
The physician will be requested:
- To include 15 consecutive patients aged > or = 65 years who will be treated with anthracyclines in first and second line MBC. The physician will be encouraged to enrol 2 arms of 8 patients (one treated with liposomal and one with non-liposomal anthracyclines) for observation and comparison. Each arm will be closed as soon as 150 patients are included at a national level.
- To report their cardiovascular risk factors
- To provide the results of routinely performed cardiac evaluation before treatment
- To monitor routinely cardiovascular parameters during treatment and report them afterwards
- To monitor efficacy and tolerance of treatments, as normal practice prescribes, reported and related to the variables described in objectives
- To ensure that quality of life will be assessed with the EORTC QLQ-C30 questionnaire
- To monitor and report progression free survival and cardiac events
- To record and transmit spontaneously reported adverse events. These will be handled according to legal requirements
Follow-up will cover a period of 15 months following inclusion.
The study will have 3 visits and 2 contacts:
- One visit at entry
- One visit after 3 cycles of anthracycline containing therapy
- One visit at the end of treatment
- Contact at 9 months after inclusion
- Contact at 15 months after inclusion
It is planned to include data from 15 consecutive female patients per specialized center in Belgium.
The total number of patients aimed is 300.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Antwerp, 벨기에, 2020
- ZNA Middelheim
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Arlon, 벨기에, 6700
- Cliniques du Sud Lux - St Joseph
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Bonheiden, 벨기에, 2820
- Imelda
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Bouge, 벨기에, 5004
- Clinique Saint-Luc
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Brasschaat, 벨기에, 2930
- AZ Klina
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Brugge, 벨기에, 8000
- AZ St Jan
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Brussel, 벨기에, 1090
- UZ Brussel
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Brussels, 벨기에, 1020
- CHU Brugmann
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Brussels, 벨기에, 1070
- Erasme
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Brussels, 벨기에, 1180
- CHIREC - Centre Hospitalier Interrégional Edith Cavell
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Chimay, 벨기에, 6460
- CSF
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Duffel, 벨기에, 2570
- AZ St-Maarten
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Edegem, 벨기에, 2650
- UZA
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Geel, 벨기에, 2440
- AZ St-Dimpna
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Ghent, 벨기에, 9000
- AZ St-Lucas
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Merksem, 벨기에, 2170
- ZNA Jan Palfijn
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Namur, 벨기에, 5000
- CMSE
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Namur, 벨기에, 5000
- CHR
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Oostende, 벨기에, 8400
- AZ Damiaan
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Ottignies, 벨기에, 1340
- Clinique St Pierre
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St-Niklaas, 벨기에, 9100
- AZ Nikolaas
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Tournai, 벨기에, 7500
- Centre Hospitalier de Wallonie picarde - site IMC
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Verviers, 벨기에, 4800
- CHPLT
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Yvoir, 벨기에, 5530
- CHU Mont-Godinne
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Belgian women aged > or = 65 years with metastatic breast cancer before and after anthracycline treatment.
Patients will be included in 24 centers specialized in the treatment of breast cancer, in Belgium.
설명
Inclusion Criteria:
- women aged 65 years old or more
- with confirmed metastatic breast cancer (MBC)
- who will be treated with anthracyclines in first or second line
- who have a Karnofsky score at baseline of 50
- who agree and are able to fill in the EORTC QLQ-C30 questionnaire
- who gave their informed consent
Exclusion Criteria:
- women having contra-Indications for anthracyclines
- women aged < 65 years old
- with no metastatic breast cancer
- who will not be eligible for an anthracycline treatment in first or second line MBC
- who have a Karnofsky less than 50
- who disagree or are unable to fill in the EORTC QLQ-C30 questionnaire
- women refusing or not having signed their informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
cardiovascular risk factors
기간: 15 months
|
15 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Christel Fontaine, MD, Universitair Ziekenhuis Brussel
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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