Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT03589456
Status:
TERMINATED
Last Update Posted:
2020-02-24
First Post:
2018-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishment of a PDT Patient Registry
Sponsor:
Concordia Laboratories Inc.
Organization:
Study Overview
Official Title:
Establishment of a Registry for Patients Treated With Photodynamic Therapy (PDT)
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed to accrual on January 15, 2020.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: