Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes (CALIPSO)
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
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.
調査の概要
詳細な説明
研究の種類
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
---|
PDT with porfimer sodium
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Proportion of patients experiencing Adverse Reactions of Special Interest
時間枠:3 months
|
Proportion of patients experiencing photosensitivity reaction, oesophageal stenosis, and/or perforation at the site of laser light application after PDT.
|
3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Incidence of the photosensitivity reaction in patients with liver insufficiency (disease)
時間枠:3 months
|
Possible differences in the incidence of the photosensitivity reaction between patients with and without liver insufficiency
|
3 months
|
Relationships between photosensitivity reaction and skin color
時間枠:3 months
|
3 months
|
|
Overall safety in patients with renal insufficiency (disease)
時間枠:3 months
|
3 months
|
協力者と研究者
スポンサー
研究記録日
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
食道がんの臨床試験
-
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