Photodynamic Therapy (PDT) Oncology Registry

NCT01842555 | Unknown

• 1 other identifier: R16-3560
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Esophageal

Keywords

PDT; Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• 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 1. 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 2. Pre-Treatment Primary Site Clinical Sta

  Up to 3 years

Secondary Outcomes (3)

• Survival following palliative and non-palliative PDT

  Up to 3 years

• Short and long term efficacy of PDT in presenting symptom improvement

  Up to 3 years

• Complications after PDT

  up to 3 years after

Study Arms (1)

PDT registry patients

Any newly diagnosed lung or esophageal cancer that is being being treated with PDT at a participating institution.

Other: Registry

Interventions

Registry OTHER

Registry

Also known as: PDT

PDT registry patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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®

Sponsors & Collaborators

• Main Line Health: lead
• Pinnacle Biologics Inc.: collaborator

Study Sites (1)

Main Line Health, Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Related Links

• Main Line Healthcare System

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Registries; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Patrick Ross, MD, PhD

  Main Line Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patsy Skabla, PA

CONTACT

SkablaP@mlhs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 29, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2024
• Study Completion: December 30, 2024
• Last Updated: August 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)