Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes
| Status: | Archived |
|---|---|
| Conditions: | Lung Cancer, Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2010 |
| End Date: | March 2016 |
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.
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.
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