Patient-reported Outcomes Following Percutaneous Ablation of Desmoid Tumors
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in desmoid tumor symptom severity following ablation
研究概览
简要总结
This study will evaluate patient-reported outcomes before and after percutaneous ablation of desmoid tumors. Adult participants undergoing ablation for desmoid tumor will complete surveys pre and post procedure to assess symptom burden, impact on daily life, early post-procedural pain and recovery, concomitant treatments, and radiological response following ablation.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
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
- Adult patients undergoing ablation for desmoid tumor.
排除标准
- Declines to participate in research.
研究组 & 干预措施
Desmoid Tumor Ablation Cohort
Adult participants undergoing percutaneous ablation for desmoid tumor who complete patient-reported outcome surveys before and after treatment.
干预措施: Desmoid tumor ablation (Procedure)
结局指标
主要结局
Change in desmoid tumor symptom severity following ablation
时间窗: Baseline; 7 days; 1, 3, 6, 12, and 24 months post-ablation
Desmoid tumor symptom severity following ablation will be measured using the GODDESS© Desmoid Tumor Symptom Scale, a disease-specific patient-reported outcome measure assessing desmoid tumor-related symptoms. Scores will be calculated according to the validated GODDESS© scoring algorithm. Higher scores indicate greater symptom burden.
Change in desmoid tumor impact following ablation
时间窗: Baseline; 7 days; 1, 3, 6, 12, and 24 months post-ablation
Desmoid tumor impact following ablation will be measured using the GODDESS© Desmoid Impact Scale, a disease-specific patient-reported outcome measure assessing desmoid tumor-related symptoms on patients' daily lives and functioning. Scores will be calculated according to the validated GODDESS© scoring algorithm. Higher scores are expected to indicate greater disease-related impact.
Change in post-procedural pain score
时间窗: Baseline; 7 days; 1 month and 3 months post-ablation
The pain score is calculated from a 2 question self-report survey asking recipients to rate pain on a scale of 1-10. Higher scores indicate worse pain.
次要结局
- Radiological response following ablation(Through 24 months post-ablation)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07755176
- 其他研究编号
- 24-011797
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否