Clinical trial NCT01842555: Photodynamic Therapy (PDT) Oncology Registry
Official title: Photodynamic Therapy (PDT) Oncology Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Esophageal
Keywords: PDT
Photodynamic therapy
Lead sponsor: Main Line Health
Sponsor class: OTHER
Collaborators: name: Pinnacle Biologics Inc.
First posted: 2013-04-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each participating center will need to describe its own mechanism for patient identification and eligibility screening.

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.

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®

Primary outcomes:
measure: A Photodynamic Therapy (PDT) research repository and de-identified registry
timeFrame: Up to 3 years
Secondary outcomes:
measure: Survival following palliative and non-palliative PDT
timeFrame: Up to 3 years
measure: Short and long term efficacy of PDT in presenting symptom improvement
timeFrame: Up to 3 years
measure: Complications after PDT
timeFrame: up to 3 years after
Other outcomes:
Locations:
city: Wynnewood
country: United States
facility: Main Line Health, Lankenau Medical Center
state: Pennsylvania
Study officials:
affiliation: Main Line Health
name: Patrick Ross, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: