Lung CancerNCT03589456
Establishment of a PDT Patient Registry
An observational study of Lung Cancer, run by Concordia Laboratories Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 22 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Jan 2019to 15 Jan 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: It is intended to enroll all types of subjects requiring PDT for cancer.
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Clinical Research Associates of Central PA
Altoona, Pennsylvania, 16602
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
John Muir Clinical Research Center
Concord, California, 94520
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32610
Alexian Brothers Hospital Network
Lisle, Illinois, 60532
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
About this study
Official title: Establishment of a Registry for Patients Treated With Photodynamic Therapy (PDT)
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- No intervention
- Keywords
- lung cancer, lung carcinoma, lung metastases, metastases
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There are no interventions associated with this registry as it is purely observational.
What is being measured
The primary outcome is the main question the study is designed to answer.
PDT Outcome
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
Measured: Up to 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start18 Jan 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Why it stopped: Study was closed to accrual on January 15, 2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 22 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Concordia Laboratories Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roswell Park Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Sandra Gollnick, Ph.D., Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589456
- Sponsor's protocol ID
- CLI-PDT1801_I 69818
- Status last verified
- Feb 2020
- First submitted
- 5 Jul 2018
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Registry for Patients Treated With Photodynamic Therapy (PDT)
- ClinicalTrials.gov ID
- NCT03589456
- Acronym / sponsor ID
- CLI-PDT1801_I 69818
- Conditions
- Lung Cancer
- Keywords
- lung cancer, lung carcinoma, lung metastases, metastases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was closed to accrual on January 15, 2020.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Concordia Laboratories Inc.Industry (pharma, biotech, devices)
- Collaborators
- Roswell Park Cancer Institute
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- It is intended to enroll all types of subjects requiring PDT for cancer.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere are no interventions associated with this registry as it is purely observational. | Other | – |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Study was closed to accrual on January 15, 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Gollnick, Ph.D. principal investigator
Roswell Park Cancer Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Concordia Laboratories Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was closed to accrual on January 15, 2020.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDT Outcome (time frame: Up to 5-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.