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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


N/A
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Lung Cancer, Barrett's Esophagus

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Trial Information

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


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.


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 PhotosanĀ®

- 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Proportion of patients experiencing Adverse Reactions of Special Interest

Outcome Description:

Proportion of patients experiencing photosensitivity reaction, oesophageal stenosis, and/or perforation at the site of laser light application after PDT.

Outcome Time Frame:

3 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MA-PO-PHORC07-01

NCT ID:

NCT01203163

Start Date:

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Lung Cancer
  • Barrett's Esophagus
  • PDT
  • porfimer sodium
  • esophageal cancer
  • NSCLC
  • HGD in BE
  • Barrett Esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms

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