Establishment of a PDT Patient Registry

Terminated

• Conditions: Lung Cancer

• Registration Number: NCT03589456
• Lead Sponsor: Concordia Laboratories Inc.

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.

Study Timeline

• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-17
• Study Start: 2019-01-18
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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.

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Exclusion Criteria

• None.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Clinical Research Associates of Central PA; 🇺🇸 Altoona, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

John Muir Clinical Research Center; 🇺🇸 Concord, California, United States

Alexian Brothers Hospital Network; 🇺🇸 Lisle, Illinois, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Providence Sacred Heart Medical Center; 🇺🇸 Spokane, Washington, United States