Photodynamic Therapy (PDT) Oncology Registry

Lung Cancer Clinical Trial

— PDT Registry  

Official title:

Photodynamic Therapy (PDT) Oncology Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01842555
• Other study ID #: R16-3560
• Status: Recruiting
• Start date: November 2012
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2018
• Source: Main Line Health
• Contact: Patsy Skabla, PA
• Email: SkablaP[@]mlhs.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Esophageal
• Lung Cancer

Intervention

Other:
• Registry
Registry

Locations

Country	Name	City	State
United States	Main Line Health, Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Main Line Health	Pinnacle Biologics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival following palliative and non-palliative PDT	calculated by date of PDT treatment and date of death (where applicable)	Up to 3 years
Secondary	Short and long term efficacy of PDT in presenting symptom improvement	Quality of Life Score before and after PDT	Up to 3 years
Secondary	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

External Links

•   Main Line Healthcare System