NCT01842555

Photodynamic Therapy (PDT) Oncology Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Main Line Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The data elements for the PDT Registry project include virtually all the elements in the standard hospital-based cancer registry record, although in some cases at a finer level of detail. All data points should be found in the participant's medical record. The principal difference between the PDT Registry data set and that collected by the registries is the inclusion of more information specific to PDT.

Detailed description

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.

Conditions

• Lung Cancer
• Esophageal

Interventions

Type	Name	Description
OTHER	Registry	Registry

Timeline

• Start date: 2012-11-01
• Primary completion: 2024-11-01
• Completion: 2024-12-30
• First posted: 2013-04-29
• Last updated: 2018-08-24

Locations

1 site across 1 country: United States