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临床试验/NCT02345915
NCT02345915Unknown不适用

Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia-LEA-JA-IPC 2014-005

Institut Paoli-Calmettes2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Quality-of-life assessment of young adult acute leukemia-survivors

研究概览

简要总结

Taking into account the specificities of adolescent and young adult cancer patients led agencies (in particular the French National Cancer Institute INCa, through the last Cancer Plan), to initiate projects targeting this population. Acute leukemia is among the most common cancers in adolescents and young adults. Recent therapeutic advances now allow hope for a cure in about 50% of this population. The issue of post-cancer is therefore of particular importance for young adults with cancer. Our aim is to establish the health determinants in young adult leukemia survivors and to compare the frequency of these effects and their explanatory factors to the data collected in children or adolescent leukemia survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer center and Nice University Hospital have been identified and would be included in this study.Collected data will include information on the initial disease and its treatments, physical sequelae (fertility, thyroid function, heart function, visual function, secondary tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic syndrome, osteonecrosis, alopecia ... ), quality of life, social and occupational integration and relationship with care system.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Young adult (18-40 years) Leukemia survivor, in complete remission.
  • Acute leukemia diagnosed since January 1980 .
  • Patient Affiliated to social security or beneficiary
  • Signed Informed Consent prior to any screening procedures

排除标准

  • Emergency
  • Patient unable to abide by the study protocol (for geographical, social or psychological reasons)

研究组 & 干预措施

Young adult acute leukemia-survivor

Other

干预措施: Blood sample (Other)

Young adult acute leukemia-survivor

Other

干预措施: Electrocardiogram (Other)

结局指标

主要结局

Quality-of-life assessment of young adult acute leukemia-survivors

时间窗: 24 mois

Quality of life questionnaire

Late sequelae evaluation of young adult acute leukemia-survivors

时间窗: 24 mois

Main measured sequelae on: heart function, thyroid function, visual function, lung function, bone metabolism, secondary tumors, viral infections, iron metabolism, metabolic syndrome, gonadic, fertility, renal function, liver function,...

次要结局

  • Comparison of the frequency of sequelae between children/adolescents (LEA cohort) and young adults acute leukemia survivors (LEA-JA)(24 mois)

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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