Photodynamic Therapy (PDT) Oncology Registry

NCT ID: NCT01842555

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2024-12-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

PDT registry patients

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

Registry

Intervention Type: OTHER

Registry

Interventions

Registry

Registry

Intervention Type: OTHER

Other Intervention Names

PDT

Eligibility Criteria

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®

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pinnacle Biologics Inc.

INDUSTRY

Sponsor Role: collaborator

Main Line Health

OTHER

Sponsor Role: lead

Responsible Party

Patrick Ross

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Ross, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health

Locations

Main Line Health, Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patsy Skabla, PA

Role: CONTACT

SkablaP@mlhs.org

Facility Contacts

Patsy Skabla, PA

Role: primary

SkablaP@mlhs.org

Related Links

http://www.mainlinehealth.org

Main Line Healthcare System

Other Identifiers

R16-3560

Identifier Type: -

Identifier Source: org_study_id