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Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain

2021년 5월 20일 업데이트: Celgene

Prospective Observational Study on Overall Survival and Quality of Life in Patients Older Than 60 Years With Acute Myeloid Leukemia Diagnosis in Spain, Treated According to Standard Clinical Practice

Prospective, multicenter, observational, national study (EPA-SP) that aims to describe the survival and the quality of life, the clinical management strategies and the prognostic factors for survival related to the patient, in a prospective cohort of patients over 60 with AML diagnosis in Spain and treated outside of clinical trials; that is, under conditions of standard clinical practice.

The study will last 24 months in total from the inclusion of the first patient until the end of the last patient's follow-up

연구 개요

상태

완전한

정황

상세 설명

Following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model:

  1. Recruitment period: One year of recruitment period, data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).
  2. Follow-up period: data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).

The patient clinical history and the study´s questionnaires will be the source documents. The study will be carried out in the facilities of the Hematology and Hemotherapy Services of the participating centers, collecting the conditions of medical action according to the standard clinical practice.

Being an observational study, no intervention out of standard clinical practice will be performed. No additional diagnostic or treatment procedures will be applied for the patients.

연구 유형

관찰

등록 (실제)

151

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 스페인
      • Madrid, 스페인, 28040
        • Fundacion Jimenez Diaz
      • Madrid, 스페인, 28006
        • Hospital Universitario La Princesa
      • Madrid, 스페인, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, 스페인, 28040
        • Hospital Clinico San Carlos
      • Madrid, 스페인, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, 스페인, 28046
        • Hospital Universitario La Paz
      • Madrid, 스페인, 28222
        • Hospital De Fuenlabrada
      • Madrid, 스페인, 28905
        • Hospital de Getafe
    • Andalucía
      • Córdoba, Andalucía, 스페인, 14004
        • Hospital Univ. Reina Sofia
      • Sevilla, Andalucía, 스페인, 41009
        • Hospital Universitario Virgen Macarena
    • Andalucía/Cádiz
      • Jerez, Andalucía/Cádiz, 스페인, 11404
        • Hospital de Jerez
    • Andalucía/Granada
      • Granada, Andalucía/Granada, 스페인, 18014
        • Hospital Virgen de las Nieves
    • Andalucía/Málaga
      • Málaga, Andalucía/Málaga, 스페인, 29010
        • Hospital Carlos Haya
    • Andalucía/Sevilla
      • Sevilla, Andalucía/Sevilla, 스페인, 41013
        • Hospital Virgen Del Rocio
      • Sevilla, Andalucía/Sevilla, 스페인, 41014
        • Hospital Universitario Nuestra Señora de Valme
    • Aragón
      • Zaragoza, Aragón, 스페인, 50009
        • Hospital Clinico Lozano Blesa
    • Asturias
      • Gijón, Asturias, 스페인, 33394
        • Hospital Universitario Cabueñes
      • Oviedo, Asturias, 스페인, 33011
        • Hospital Universitario Central de Asturias
    • Baleares
      • Palma de Mallorca, Baleares, 스페인, 07120
        • Hospital Son Espases
    • Castilla-León
      • Burgos, Castilla-León, 스페인, 09006
        • Hospital Universitario de Burgos
      • León, Castilla-León, 스페인, 24071
        • Hospital de Leon
      • Salamanca, Castilla-León, 스페인, 37120
        • Complejo Hospitalario de Salamanca
      • Valladolid, Castilla-León, 스페인, 47003
        • Clínico de Valladolid
    • Cataluña
      • Barcelona, Cataluña, 스페인, 08003
        • Hospital del Mar
      • Lleida, Cataluña, 스페인, 25198
        • Hospital Arnau de Vilanova Lleida
      • Manresa, Barcelona, Cataluña, 스페인, 08243
        • Hospital de Althaia (H. Sant Juan de Deu de Manresa)
    • Comunidad Madrid
      • Madrid, Comunidad Madrid, 스페인, 28031
        • Hospital Infanta Leonor
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, 스페인, 03010
        • Hospital General Alicante
      • Valencia, Comunidad Valenciana, 스페인, 46014
        • Hospital General Universitario de Valencia
    • Extremadura
      • Badajoz, Extremadura, 스페인, 06080
        • Hospital Infanta Cristina
    • Galicia
      • La Coruña, Galicia, 스페인, 15006
        • Complejo Hospitalario Universitario de A Coruña
      • Ourense, Galicia, 스페인, 32005
        • Complejo Hospitalario Universitario de Orense
    • Islas Canarias
      • Las Palmas de Gran Canaria, Islas Canarias, 스페인, 35010
        • Hospital Dr. Negrín
      • Santa Cruz de Tenerife, Islas Canarias, 스페인, 38010
        • Hospital Nuestra Señora de Candelaria
      • Santa Cruz de Tenerife, Islas Canarias, 스페인, 38320
        • Hospital Universitario Canarias
    • Murcia
      • Cartagena, Murcia, Murcia, 스페인, 30202
        • Hospital Santa Lucía
    • Navarra
      • Pamplona, Navarra, Navarra, 스페인, 31008
        • Complejo Hospitalario de Navarra
    • País Vasco
      • Bilbao, Vizcaya, País Vasco, 스페인, 48013
        • Hospital de Basurto
      • San Sebastián, Guipúzcoa, País Vasco, 스페인, 20014
        • Hospital Universitario de Donostia
      • Vitoria, País Vasco, 스페인, 01009
        • Hospital de Txagorritxu

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

60년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

The study population will consist of approximately 150 patients over 60 with AML diagnosis, defined according to World Health Organization (WHO) 2016 criteria (presence of blasts in the bone marrow or peripheral blood equal to or greater than 20%).

Due to the observational and descriptive nature of the present investigation, the inclusion of a control group is not considered.

설명

Inclusion Criteria:

  • Patient of both sexes, aged 65 years and older.
  • Any race, nationality or socioeconomic status.
  • AML (defined according to WHO 2016 criteria de novo, with previous hematological history or secondary.
  • Diagnosis date later than 1st November 2017 and later than each center activation date.
  • Patients on first line treatment with any therapeutic strategy (intensive, attenuated or palliative).
  • Having given informed consent prior to start the data collection.

Exclusion Criteria:

  • Inability to understand the informed consent form.
  • AML previously treated (with or without HSCT).
  • Acute promyelocytic leukemia.
  • Participation in a clinical trial that includes first-line treatment for AML.
  • Do not grant consent.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
Patients diagnosed with AML
The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The median survival time in adult patients over 60 with AML diagnosis
기간: Up to approximately 12 months
The overall survival will be calculated, defined as the time from the diagnosis date to the death date from any reason. In patients who have not died (censored) at the time of data collection, it will be considered the available time to the last control (or last date). The overall survival will be analyzed using the Kaplan-Meier method, providing the median at 95% CI. Patients who undergo a hematopoietic transplant will be censored at that time.
Up to approximately 12 months

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival
기간: Up to approximately 12 months
The Kaplan Meier curve, with the median and the lower and upper limits of the 95% confidence interval, will be reported.
Up to approximately 12 months
To describe the socio-demographic and clinical characteristics of patients
기간: Up to approximately 12 months
A description of the study socio-demographic and clinical variables will be made. The distributions of absolute and relative frequencies of the qualitative variables will be reported, as well as the measures of central and dispersion tendency of the quantitative variables. A 95% CIs will be obtained for the main variables.
Up to approximately 12 months
To describe the disease characteristics
기간: Up to approximately 12 months
A description of the variables that characterize the disease under study will be made. The distributions of absolute and relative frequencies of the qualitative variables will be reported, as the measures of central tendency and dispersion of the quantitative variables. A 95% CIs will be obtained for the main variables.
Up to approximately 12 months
To describe the front-line treatment strategies
기간: Up to approximately 12 months
The frequency distributions for the first lines of treatment will be presented, as well as the rate distribution of the most frequent treatment sequences and their evolution. It will be reported the descriptive statistics period of the first treatment lines.
Up to approximately 12 months
To assess the HRQOL evolution over time
기간: Up to approximately 12 months
Descriptive statistics will be reported for each of the five dimensions at every period of application of the EQ-5D, so as an overall lineal model of repeated measures for the VAS.
Up to approximately 12 months
To evaluate the impact on early mortality
기간: Up to approximately 8 weeks
The t-test will be used to evaluate the impact of the initial leukocyte count on early mortality (dichotomous variable minus death or not in the first 8 weeks). The stratified analysis with the same approach will be done for treatments that achieve a sufficient sample.
Up to approximately 8 weeks
To evaluate the prognostic impact on overall survival
기간: Up to approximately 12 months
A Cox regression model will be made considering the patient survival as a dependent variable and as possible factors the subjective variables (asthenia and HRQOL) at the time of diagnosis, the patient's general condition, and any other clinical variable that is evaluated as possible predictor. No more than 10 independent variables will be included in the model for theoretical reasons.
Up to approximately 12 months
To explore the scales scores to be used as potential predictors tools of treatment tolerability in patients with newly diagnosed AML.
기간: Up to approximately 12 months
The therapeutic approach will be collected according to the investigator clinical judgment, the score of each of the items on the Lee and GAH scales and the treatment administered tolerability assessment according to the score obtained in each scale. The weighting coefficients will be calculated using a complete multiple linear regression model and a multiple logistic regression. The optimal cut points for use as a predictive tool for treatment tolerability will be determined by using the ROC curve technique.
Up to approximately 12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Celgene

수사관

  • 연구 책임자: Montserrat Rafel, RML Advocacy, Celgene

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 2월 28일

기본 완료 (실제)

2020년 4월 30일

연구 완료 (실제)

2020년 4월 30일

연구 등록 날짜

최초 제출

2018년 2월 5일

QC 기준을 충족하는 최초 제출

2018년 2월 9일

처음 게시됨 (실제)

2018년 2월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 5월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 5월 20일

마지막으로 확인됨

2021년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NDS-AML-001
  • U1111-1207-6661 (레지스트리 식별자: UTN)

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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