Clinical trial NCT03589456: Establishment of a PDT Patient Registry
Official title: Establishment of a Registry for Patients Treated With Photodynamic Therapy (PDT)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: lung cancer
lung carcinoma
lung metastases
metastases
Lead sponsor: Concordia Laboratories Inc.
Sponsor class: INDUSTRY
Collaborators: name: Roswell Park Cancer Institute
First posted: 2018-07-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is intended to enroll all types of subjects requiring PDT for cancer.

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.

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.

Eligibility 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.

Primary outcomes:
measure: PDT Outcome
timeFrame: Up to 5-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Clinical Research Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lisle
country: United States
facility: Alexian Brothers Hospital Network
state: Illinois
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Altoona
country: United States
facility: Clinical Research Associates of Central PA
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Roswell Park Cancer Institute
name: Sandra Gollnick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: