An Observational European Multi-database Linkage Study to Quantify Malignancy Rates in Crohn's Disease Patients With Complex Perianal Fistula Treated With Darvadstrocel
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 5,850
- 试验地点
- 4
- 主要终点
- Incidence Rate of Malignancies Among Participants With CPF-CD
研究概览
简要总结
The main aim is to learn about the risk of cancer after treatment with darvadstrocel compared to other standards of care in people with Crohn's Disease (CD).
In this study, the study doctors will review each participant's past medical records. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.
详细描述
This is a retrospective, non-interventional study of participants with complex perianal fistula in Crohn's disease (CPF-CD). This study will assess tumorigenicity risk and all-cause and cancer-specific mortality in participants with darvadstrocel.
The study will enroll approximately 5850 participants. Data will be collected retrospectively from European secondary data sources. Participants will be assigned to two cohorts:
- Darvadstrocel cohort
- Matched control cohort: Alternate SoC.
This multi-center trial will be conducted in France, Germany, Netherlands, and Spain. The overall duration of the study will be approximately 96 months, including index period (the time in which eligible participants are included in the study) and 12 months follow-up period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Darvadstrocel cohort
- •Participants will be included in the darvadstrocel cohort if they have at least one record of prescription/dispensation/administration of darvadstrocel at some point during the study period.
- •Comparator cohort
- •A comparator cohort of controls (matched control cohort) will be composed of participants with CD and PF randomly selected from a pool of eligible participants with no history of administration of darvadstrocel.
排除标准
- •Has less than 12 months of uninterrupted data within country-specific data source prior to index date.
- •Has not meet quality indicators for country-specific data source (if applicable).
- •Has diagnosis of cancer prior different from non-melanoma skin cancer to index date. This will minimise the misclassification of prevalent or metastatic cancer as incident cases for the analysis of the study objectives.
- •Has diagnosis of ulcerative colitis at any point during the study period and medical history period. This will avoid potential ascertainment bias as there is currently no gold standard for differential diagnosis in IBD. Approximately 5 percent (%) to 15% of cases do not meet strict criteria for either ulcerative colitis (UC) or CD and in up to 14% of participants classified as UC and CD, the diagnosis changes over time.
- •Has record of proctectomy or colectomy prior to index date. Proctectomy and colectomy are considered "last chance" surgery options for anal fistulas or other complications of CD. These participants are not the target population for darvadstrocel. They would not be eligible for darvadstrocel administration and loss of their gastrointestinal tract would affect the risk of colorectal cancer; the most common cancer associated with CD.
结局指标
主要结局
Incidence Rate of Malignancies Among Participants With CPF-CD
时间窗: Up to Month 96
Incidence rate of malignancies will be calculated as the number of newly observed cases divided by the person-years of follow-up during that period.
Cumulative Incidence of Malignancies Among Participants With CPF-CD
时间窗: Up to Month 96
Cumulative incidence rate within a period will be calculated as the ratio of newly observed cases divided by the population at risk during that period.
次要结局
- All-cause Mortality Rate Among Participants With CPF-CD(Up to Month 96)
- Number of Participants With CPF-CD Characterized by Pharmacological Therapies(Up to Month 96)
- Cancer-specific Mortality Rate Among Participants With CPF-CD(Up to Month 96)
- Number of Participants With Comorbidities(Up to Month 96)
- Number of Participants With Anal Fistula Surgery(Up to Month 96)
- Number of Participants With Colorectal Surgery(Up to Month 96)