Photodynamic Therapy (PDT) Oncology Registry



Status:Recruiting
Conditions:Lung Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/26/2018
Start Date:November 2012
End Date:December 30, 2024
Contact:Patsy Skabla, PA
Email:SkablaP@mlhs.org

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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.

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.

Inclusion Criteria:

- 18 years of age or older, male or female, diagnosed with cancer and is undergoing or
has undergone Photodynamic Therapy (PDT).

- Patients must have undergone PDT with Photofrin® at a participating institution.

- Patients scheduled to undergo PDT with Photofrin®

- Cancer patients receiving some or all primary care (e.g.,cancer-directed surgery,
systemic therapy, radiation therapy, palliative care)in the participating institution.

- Cancer patients with a history of any type of cancer who have been no evidence of
disease(for five years but without a history of distant metastases or evidence of
relapse if they meet the previous criteria).

Exclusion Criteria:

- Cancer patients who present to the participating institution with a diagnosis of a
simultaneous second primary.

- Cancer patients receiving all primary cancer care (e.g., cancer-directed surgery,
chemotherapy, targeted therapy, radiation therapy, palliative care) outside of
participating institution.

- Patients treated with photosensitizers other than Photofrin®
We found this trial at
1
site
Wynnewood, Pennsylvania 19096
Principal Investigator: Patrick Ross, MD, PhD
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mi
from
Wynnewood, PA
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