NCT05570279进行中（未招募）不适用
PLAN-A - Data- Bio-and Plan-bank Collection in Patients Treated With Radiotherapy for Squamous Cell Carcinoma of the Anus in Denmark - a DACG Cooperation
Aarhus University Hospital3 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 314
- 试验地点
- 3
- 主要终点
- Complete clinical response
研究概览
简要总结
The study is a prospective registration of treatment related-, toxicity-, Quality of life- and outcome data from patients treated in Denmark with radiotherapy for squamous cell carcinoma of the anus (SCCA), as a cooperation within the Danish Anal Cancer Group (DACG).
Substudy one: A prospective biobank is collected with the purpose to identify predictive and prognostic markers for outcome.
Substudy two: MRI scans are performed to investigate the rate of pelvic insufficience fractures at one year post chemoradiotherapy.
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
- •Squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy
- •Written and oral consent
排除标准
- •Contraindication to blood sampling or MRI scans (substudy 1 and 2)
- •Other malignant disease within 5 years except from basal cell carcinomas
结局指标
主要结局
Complete clinical response
时间窗: 3 years
Rate of complete response to primary treatment as defined by clinical and radiological evaluation
次要结局
- Early toxicity evaluation by CTCAE(2 weeks after the last day of therapy)
- Late toxicity evaluation by CTCAE(1 and 3 years post treatment)
- Quality of life assessed by the EORTC QoL questionaires(2 weeks, 1 and 3 years post therapy)
- Prognostic value of ctDNA(At time of treatment completion, an average of 30 days, 1 and 3 years post therapy)
- Incidence of pelvis fractures(1 and 3 years post therapy)
研究者
Karen-Lise Garm Spindler
Professor
Aarhus University Hospital
研究点 (3)
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