Establishment of a PDT Patient Registry

NCT ID: NCT03589456

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-18

Study Completion Date

2020-01-15

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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No intervention

There are no interventions associated with this registry as it is purely observational.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role collaborator

Concordia Laboratories Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra Gollnick, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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John Muir Clinical Research Center

Concord, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Alexian Brothers Hospital Network

Lisle, Illinois, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Clinical Research Associates of Central PA

Altoona, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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CLI-PDT1801_I 69818

Identifier Type: -

Identifier Source: org_study_id

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