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Establishment of a PDT Patient Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589456
Recruitment Status : Terminated (Study was closed to accrual on January 15, 2020.)
First Posted : July 17, 2018
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Concordia Laboratories Inc.

Study Description
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Brief Summary:
This is a non-intervention patient registry to gather data on the use of photodynamic therapy under real-life conditions. It will involve up to 20 sites in USA.

Condition or disease Intervention/treatment
Lung Cancer Other: No intervention

Detailed Description:
The purpose of this patient registry is to collect information about a patient's cancer treatment, photodynamic therapy (PDT), used alone or in combination with surgery, chemotherapy and radiotherapy. Patients will be registered either before or after PDT is performed, regardless of the indication. Analysis of this information may help to refine the treatment care. Data collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (photodynamic therapy, radiation, chemotherapy, surgery, etc.), side effects, and survival outcomes. By participating in this registry, patients will not be asked to do anything that would not ordinarily be done as a matter of routine care including clinical assessments, laboratory tests, radiology procedures, and treatments. Information on disease, condition, and treatment will be recorded in the registry during routine visits.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Establishment of a Registry for Patients Treated With Photodynamic Therapy (PDT)
Actual Study Start Date : January 18, 2019
Actual Primary Completion Date : January 15, 2020
Actual Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    There are no interventions associated with this registry as it is purely observational.

Outcome Measures
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Primary Outcome Measures :
  1. PDT Outcome [ Time Frame: Up to 5-year follow-up ]
    Collection of information on patient characteristics, disease sites, and utilization of prior or combined treatments to evaluate the impact of these parameters on the treatment outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
It is intended to enroll all types of subjects requiring PDT for cancer.
Criteria

Inclusion Criteria:

  • All adult patients (≥ 18 years of age) treated with PDT.
  • Women and men and members of all races and ethnic groups.
  • Subjects may have received prior treatment for their cancer.
  • Subjects to give a written informed consent for prospectively collected data.

Exclusion Criteria:

  • None.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589456


Locations
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United States, California
John Muir Clinical Research Center
Concord, California, United States, 94520
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Alexian Brothers Hospital Network
Lisle, Illinois, United States, 60532
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Clinical Research Associates of Central PA
Altoona, Pennsylvania, United States, 16602
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Concordia Laboratories Inc.
Roswell Park Cancer Institute
Investigators
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Principal Investigator: Sandra Gollnick, Ph.D. Roswell Park Cancer Institute
More Information
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Additional Information:

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Responsible Party: Concordia Laboratories Inc.
ClinicalTrials.gov Identifier: NCT03589456    
Other Study ID Numbers: CLI-PDT1801_I 69818
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Concordia Laboratories Inc.:
lung cancer
lung carcinoma
lung metastases
metastases
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases