Case Analysis on Real Life Incidence of PDT Safety Outcomes: Multicentre, Observational Post-marketing Safety Surveillance Registry of Patients Exposed to Photodynamic Therapy With Porfimer Sodium: The CALIPSO Registry
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Proportion of patients experiencing Adverse Reactions of Special Interest
研究概览
简要总结
Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn), oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated area (a tear or puncture of the tissue), have been identified in research studies evaluating photodynamic therapy (PDT) with porfimer sodium. Because of the low incidence of the disease or the variation in the occurrence of these adverse reactions among different indications, it is difficult to determine the occurrence and frequency of these safety issues in routine clinical practice.
This post-marketing safety surveillance registry is set-up to evaluate the safety of PDT using porfimer sodium. A registry allows the collection of data to evaluate real-world results in the practice of medicine. The registry will monitor the patient's health and any events, with a main focus on photosensitivity, oesophageal stenosis, and perforation of the treated area. This registry will involve 500 patients, across 20 to 36 hospitals in the US and Europe, scheduled to receive an injection of porfimer sodium with PDT for the treatment of lung cancer, esophageal [food pipe] cancer, or high-grade dysplasia (HGD) (precancerous change in the food pipe tissue) in Barrett's esophagus.
详细描述
Patients will be enrolled in the registry upon injection of the porfimer sodium. During normal medical examination, criteria for entry onto the registry will be verified to confirm eligibility, and medical procedures including demographic information, disease history, medical history, physical exam, and clinical laboratory testing performed under normal practice will be collected. Patients will receive PDT as per current practice and will be repeated as per the physician's judgment. All patients will be assessed as per current practice, that is usually at least three times, after a PDT session. Additional visits will be sought for those patients who are presenting photosensitivity reaction, esophageal stenosis, perforation at the site of laser light application, or any unresolved serious adverse reactions at the third visit after treatment. All patients will be requested by their physician to complete a two-part Daily Diary to record adverse reactions using a check-list form and a general section for reporting any adverse events and intake of concomitant medications at the time of the adverse event.
研究设计
- 研究类型
- Observational
- 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
- •Patients scheduled to undergo PDT with Photofrin
- •Patients must have the mental, literate, and legal ability to give a written informed consent, which must comply with the International Conference on Harmonization (ICH) guidelines and local requirements.
排除标准
- •Patients treated with Photosan®
- •Patients being treated with any investigational drug or participating in any interventional studies, with the exception of investigational photoprotection measures.
- •Patients who are unable or unwilling to complete the follow-up evaluations required for the registry.
结局指标
主要结局
Proportion of patients experiencing Adverse Reactions of Special Interest
时间窗: 3 months
Proportion of patients experiencing photosensitivity reaction, oesophageal stenosis, and/or perforation at the site of laser light application after PDT.
次要结局
- Incidence of the photosensitivity reaction in patients with liver insufficiency (disease)(3 months)
- Relationships between photosensitivity reaction and skin color(3 months)
- Overall safety in patients with renal insufficiency (disease)(3 months)