Photodynamic Therapy (PDT) Oncology Registry (PDT Registry)

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Esophageal
• Intervention / Treatment: Other: Registry

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Patsy Skabla, PA; Email: SkablaP@mlhs.org

Study Locations

• United States
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Recruiting
      • Main Line Health, Lankenau Medical Center
      • Contact: Patsy Skabla, PA; Email: SkablaP@mlhs.org
      • Principal Investigator: Patrick Ross, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Each participating center will need to describe its own mechanism for patient identification and eligibility screening.

Description

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®

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PDT registry patients; Any newly diagnosed lung or esophageal cancer that is being being treated with PDT at a participating institution.	Other: Registry; Registry; Other Names: PDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A Photodynamic Therapy (PDT) research repository and de-identified registry	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 Surgeon ID Date of Birth Age at PDT Racial Background Gender Tobacco Use Alcohol Use Vital Status; Pre-Treatment Primary Site Clinical Sta	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival following palliative and non-palliative PDT	calculated by date of PDT treatment and date of death (where applicable)	Up to 3 years
Short and long term efficacy of PDT in presenting symptom improvement	Quality of Life Score before and after PDT	Up to 3 years
Complications after PDT	30-day mortality (yes/no), length of stay in hospital (number of days), assessment of PDT-related complications (ex: phototoxic reaction (yes/no), urgent re-bronchoscopy (yes/no))	up to 3 years after

Collaborators and Investigators

• Sponsor: Main Line Health
• Collaborators: Pinnacle Biologics Inc.
• Investigators: Principal Investigator: Patrick Ross, MD, PhD, Main Line Health

Publications and helpful links

Helpful Links

• Main Line Healthcare System

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: April 24, 2013
• First Posted (Estimate): April 29, 2013

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Photodynamic therapy; PDT
• Other Study ID Numbers: R16-3560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES