Photodynamic Therapy (PDT) Oncology Registry

Last updated: August 23, 2018
Sponsor: Main Line Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Cancer

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT01842555
R16-3560
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older, male or female, diagnosed with cancer and is undergoing orhas 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 ofdisease(for five years but without a history of distant metastases or evidence ofrelapse if they meet the previous criteria).

Exclusion

Exclusion Criteria:

  • Cancer patients who present to the participating institution with a diagnosis of asimultaneous second primary.

  • Cancer patients receiving all primary cancer care (e.g., cancer-directed surgery,chemotherapy, targeted therapy, radiation therapy, palliative care) outside ofparticipating institution.

  • Patients treated with photosensitizers other than Photofrin®

Study Design

Total Participants: 1000
Study Start date:
November 01, 2012
Estimated Completion Date:
December 30, 2024

Study 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.

Connect with a study center

  • UAB-University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • West Coast Associates for Minimally Invasive Thoracic Surgery at Cedars-Sinai

    Los Angeles, California 90048
    United States

    Site Not Available

  • Emory Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Cancer Treatment Centers of America (CTCA)-Southeastern Regional Medical Center

    Newnan, Georgia 30625
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Main Line Health

    Lankenau Medical Center, Pennsylvania 19096
    United States

    Site Not Available

  • Cancer Treatment Centers of America (CTCA)- Eastern Regional Medical Center

    Philadelphia, Pennsylvania 19124
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Main Line Health, Lankenau Medical Center

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Providence Medical Center

    Spokane, Washington 99204
    United States

    Site Not Available

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