Establishment of a PDT Patient Registry

Sponsor

Concordia Laboratories Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT03589456

Collaborator

Roswell Park Cancer Institute (Other)

Enrollment

Locations

11.9

Actual Duration (Months)

2.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

22 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

Establishment of a Registry for Patients Treated With Photodynamic Therapy (PDT)

Actual Study Start Date :

Jan 18, 2019

Actual Primary Completion Date :

Jan 15, 2020

Actual Study Completion Date :

Jan 15, 2020

Outcome Measures

Primary Outcome Measures

PDT Outcome [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	John Muir Clinical Research Center	Concord	California	United States	94520
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	University of Florida	Gainesville	Florida	United States	32610
4	University of Chicago	Chicago	Illinois	United States	60637
5	Alexian Brothers Hospital Network	Lisle	Illinois	United States	60532
6	Duke University Medical Center	Durham	North Carolina	United States	27710
7	Clinical Research Associates of Central PA	Altoona	Pennsylvania	United States	16602
8	Medical University of South Carolina	Charleston	South Carolina	United States	29425
9	Providence Sacred Heart Medical Center	Spokane	Washington	United States	99204
10	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

Concordia Laboratories Inc.
Roswell Park Cancer Institute

Investigators

Principal Investigator: Sandra Gollnick, Ph.D., Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Concordia Laboratories Inc.

ClinicalTrials.gov Identifier:

NCT03589456

Other Study ID Numbers:

CLI-PDT1801_I 69818

First Posted:

Jul 17, 2018

Last Update Posted:

Feb 24, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Concordia Laboratories Inc.

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Feb 24, 2020