NCT03562091已完成不适用
Observational Study on Perception of Information and Quality of Life in Neuroendocrine Tumor on Lanreotide Autogel
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Absolute variation on the score (standardized on a scale from 0 to 100) of the 3 targeted dimensions (disease, treatments and supportive care) of the self-administered Quality of Life Questionnaire (QLQ) QLQINFO25
研究概览
简要总结
The purpose of the study is to evaluate, in standard practice, the change in information received and perceived by the patient, extension of the disease and its treatment. These parameters will be evaluated by means of validated self-administered questionnaires that can be used in standard practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastroenteropancreatic neuroendocrine tumor (GEPNET), histologically proven, grade
- •Subject eligible for antitumor treatment initiation with lanreotide autogel*, alone or combined with other therapies, selected freely and prior to inclusion in the study by the physician,
- •Subject able to complete a self-administered evaluation questionnaire during initiation visit and liable to be seen again within 6 months of the initial visit based on the physician's usual practices
- •Having consented in writing to his/her data being accessed for participation in the study.
排除标准
- •Previously treated by lanreotide autogel
- •Simultaneously participating in a clinical trial
结局指标
主要结局
Absolute variation on the score (standardized on a scale from 0 to 100) of the 3 targeted dimensions (disease, treatments and supportive care) of the self-administered Quality of Life Questionnaire (QLQ) QLQINFO25
时间窗: Change from Baseline to Month 6
次要结局
- Progression (yes/no) of NET on imaging as part of the monitoring of the NET(Month 3 and Month 6)
- Change from baseline to Month 3 of the 3 targeted dimensions (disease, treatments and supportive care (ie, other services)) of QLQ-INFO25 self-administered questionnaire(Change from Baseline to Month 3)
- Changes from baseline to Month 3 and Month 6 on dimensions of the QLQ-INFO25 self-administered questionnaire not part of the primary endpoint(Change from Baseline to Month 3 and 6)
- Changes of symptoms assessments (presence of symptoms or not) as part of the monitoring of the Neuroendocrine Tumor (NET)(Change from Baseline to Month 3 and to Month 6)
- Change from baseline to Month 3 and Month 6 in quality of life using QLQ-C30 questionnaire(Change from Baseline to Month 3 and Month 6)
- Changes of biochemical markers expressed in terms of results (decrease, stable, increase) as part of the monitoring of the NET(Change from Baseline to Month 3 and to Month 6)
研究者
研究点 (1)
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