Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia-LEA-JA-IPC 2014-005
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
- 否
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
干预措施: Blood sample (Other)
Young adult acute leukemia-survivor
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)
