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Establishment of a PDT Patient Registry

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ClinicalTrials.gov Identifier: NCT03589456
Recruitment Status : Not yet recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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 Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Establishment of a Registry for Patients Treated With Photodynamic Therapy (PDT)
Estimated Study Start Date : July 15, 2018
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. PDT Outcome [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
It is intended to enroll all types of subjects requiring PDT for cancer.
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:

  • Subjects participating in any interventional studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589456


Contacts
Contact: Kristen Anton 802-384-4566 Kristen.Anton@RoswellPark.org
Contact: Sandra Gollnick, Ph.D. 716-845-8877 Sandra.Gollnick@RoswellPark.org

Sponsors and Collaborators
Concordia Laboratories Inc.
Roswell Park Cancer Institute
Investigators
Principal Investigator: Sandra Gollnick, Ph.D. Roswell Park Cancer Institute

Responsible Party: Concordia Laboratories Inc.
ClinicalTrials.gov Identifier: NCT03589456     History of Changes
Other Study ID Numbers: CLI-PDT1801_I 69818
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Concordia Laboratories Inc.:
lung cancer
lung carcinoma
lung metastases
metastases