ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 277977 for:    ALL
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03589456
Recruitment Status : Not yet recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Concordia Laboratories Inc.

July 5, 2018
July 17, 2018
July 17, 2018
July 15, 2018
July 15, 2023   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Establishment of a PDT Patient Registry
Establishment of a Registry for Patients Treated With Photodynamic Therapy (PDT)
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.
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.
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Other
5 Years
Not Provided
Non-Probability Sample
It is intended to enroll all types of subjects requiring PDT for cancer.
Lung Cancer
Other: No intervention
There are no interventions associated with this registry as it is purely observational.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1000
Same as current
December 15, 2023
July 15, 2023   (Final data collection date for primary outcome measure)

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:

  • Subjects participating in any interventional studies.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Not Provided
Contact: Kristen Anton 802-384-4566 Kristen.Anton@RoswellPark.org
Contact: Sandra Gollnick, Ph.D. 716-845-8877 Sandra.Gollnick@RoswellPark.org
Not Provided
 
 
NCT03589456
CLI-PDT1801_I 69818
No
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
Not Provided
Concordia Laboratories Inc.
Concordia Laboratories Inc.
Roswell Park Cancer Institute
Principal Investigator: Sandra Gollnick, Ph.D. Roswell Park Cancer Institute
Concordia Laboratories Inc.
July 2018