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Photodynamic Therapy (PDT) Oncology Registry

18 Years
Open (Enrolling)
Lung Cancer, Esophageal

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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.

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

- 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®

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort

Outcome Measure:

A Photodynamic Therapy (PDT) research repository and de-identified registry

Outcome Description:

Participating sites will be able to utilize aggregate, de-identified data to perform research on PDT, the patients receiving PDT, and their outcomes and complications after the procedure. Data collected includes the following: Table 1. Outline of Data Elements in the PDT Registry Patient Visit Form- Demographics Patient Identification Number Institution Number Study Type (retrospective or prospective) Surgeon ID Date of Birth Age at PDT Racial Background Gender Tobacco Use Alcohol Use Vital Status Pre-Treatment Primary Site Clinical Sta

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Patrick Ross, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

November 2012

Completion Date:

Related Keywords:

  • Lung Cancer
  • Esophageal
  • PDT
  • Photodynamic therapy
  • Esophageal Diseases
  • Lung Neoplasms



University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Duke University Medical CenterDurham, North Carolina  27710
Ohio State University Medical CenterColumbus, Ohio  43210
Emory Winship Cancer InstituteAtlanta, Georgia  30322
UAB-University of Alabama at BirminghamBirmingham, Alabama  35233
West Coast Associates for Minimally Invasive Thoracic SurgeryLos Angeles, California  90048
Cancer Treatment Centers of American (CTCA)Newnan, Georgia  30625
Providence Medical CenterSpokane, Washington  99204