Establishment of a PDT Patient Registry

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03589456
• Other study ID #: CLI-PDT1801_I 69818
• Status: Terminated
• Start date: January 18, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: February 2020
• Source: Concordia Laboratories Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• No intervention
There are no interventions associated with this registry as it is purely observational.

Locations

Country	Name	City	State
United States	Clinical Research Associates of Central PA	Altoona	Pennsylvania
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	John Muir Clinical Research Center	Concord	California
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Alexian Brothers Hospital Network	Lisle	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Providence Sacred Heart Medical Center	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Concordia Laboratories Inc.	Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDT Outcome	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	Up to 5-year follow-up