Photodynamic Therapy (PDT) Oncology Registry

Trial Information

Photodynamic Therapy (PDT) Oncology Registry

Participating centers will need to describe its own mechanism for patient identification and
eligibility screening. A data manager, identified by the Principal Investigator at each
participating center, will screen all patients for eligibility. Appointment, diagnosis and
treatment data will be reviewed using information such as clinic records, appointment lists,
pathology department records, OR schedule and/or tumor registries. Patients meeting
inclusion criteria will be enrolled in the 3-year registry which will comprise retrospective
and prospective parts. Patients will be accrued retrospectively for the first 12-month
period of the registry. The retrospective part will include patients who received PDT with
Photofrin® from 2007 up to 2012. Patients who are eligible but die prior to enrollment will
also be included to minimize bias resulting from non-inclusion of advanced stage patients.
The prospective recruitment parts will be three years. The estimated length of follow-up for
each patient will be 3 years. Follow-up will be conducted by research study staff at each
institution via medical record review, under the direction of the Principal Investigator at
that site. No patients will be contacted at any point to obtain study data or for follow-up.