Lung CancerPDT RegistryNCT01842555
Photodynamic Therapy (PDT) Oncology Registry
An observational study of Lung Cancer and Esophageal, run by Main Line Health at 1 site in United States.
Trial summary
The data elements for the PDT Registry project include virtually all the elements in the standard hospital-based cancer registry record, although in some cases at a finer level of detail. All data points should be found in the participant's medical record. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Esophageal
- What is being tested?
- Registry
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 30 Dec 2024
- How long will I take part?
- 3 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
- No healthy volunteers
- Adult, Older adult
Study population: Each participating center will need to describe its own mechanism for patient identification and eligibility screening.
Who may be able to join
- 18 years of age or older, male or female, diagnosed with cancer and is undergoing or has undergone Photodynamic Therapy (PDT).
- Patients must have undergone PDT with Photofrin® at a participating institution.
- Patients scheduled to undergo PDT with Photofrin®
- Cancer patients receiving some or all primary care (e.g.,cancer-directed surgery, systemic therapy, radiation therapy, palliative care)in the participating institution.
- Cancer patients with a history of any type of cancer who have been no evidence of disease(for five years but without a history of distant metastases or evidence of relapse if they meet the previous criteria).
Who cannot join
- Cancer patients who present to the participating institution with a diagnosis of a simultaneous second primary.
- Cancer patients receiving all primary cancer care (e.g., cancer-directed surgery, chemotherapy, targeted therapy, radiation therapy, palliative care) outside of participating institution.
- Patients treated with photosensitizers other than Photofrin®
Trial locations and contacts
1 site in 1 country.
Patsy Skabla, PA contact
United States1 site, 1 recruiting
- Recruiting
Main Line Health, Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Patsy Skabla, PA, SkablaP@mlhs.org
Patrick Ross, MD, PhD
About this study
The data elements for the PDT Registry project include virtually all the elements in the standard hospital-based cancer registry record, although in some cases at a finer level of detail. All data points should be found in the participant's medical record. The principal difference between the PDT Registry data set and that collected by the registries is the inclusion of more information specific to PDT.
Read the detailed description
Participating centers will need to describe its own mechanism for patient identification and eligibility screening. A data manager, identified by the Principal Investigator at each participating center, will screen all patients for eligibility. Appointment, diagnosis and treatment data will be reviewed using information such as clinic records, appointment lists, pathology department records, OR schedule and/or tumor registries. Patients meeting inclusion criteria will be enrolled in the 3-year registry which will comprise retrospective and prospective parts. Patients will be accrued retrospectively for the first 12-month period of the registry. The retrospective part will include patients who received PDT with Photofrin® from 2007 up to 2012. Patients who are eligible but die prior to enrollment will also be included to minimize bias resulting from non-inclusion of advanced stage patients. The prospective recruitment parts will be three years. The estimated length of follow-up for each patient will be 3 years. Follow-up will be conducted by research study staff at each institution via medical record review, under the direction of the Principal Investigator at that site. No patients will be contacted at any point to obtain study data or for follow-up.
- Conditions
- Lung Cancer, Esophageal
- Being tested
- Registry
- Keywords
- PDT, Photodynamic therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
Also called PDT
Registry
| Study group | Role | What they receive |
|---|---|---|
| PDT registry patients | Any newly diagnosed lung or esophageal cancer that is being being treated with PDT at a participating institution. Receives: Other: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Photodynamic Therapy (PDT) research repository and de-identified registry
Participating sites will be able to utilize aggregate, de-identified data to perform research on PDT, the patients receiving PDT, and their outcomes and complications after the procedure.
Data collected includes the following:
Table 1. Outline of Data Elements in the PDT Registry
- Patient Visit Form- Demographics Patient Identification Number Institution Number Study Type Surgeon ID Date of Birth Age at PDT Racial Background Gender Tobacco Use Alcohol Use Vital Status
- Pre-Treatment Primary Site Clinical Sta
Measured: Up to 3 years
Secondary outcomes (3)
Survival following palliative and non-palliative PDT
calculated by date of PDT treatment and date of death (where applicable)
Measured: Up to 3 years
Short and long term efficacy of PDT in presenting symptom improvement
Quality of Life Score before and after PDT
Measured: Up to 3 years
Complications after PDT
30-day mortality (yes/no), length of stay in hospital (number of days), assessment of PDT-related complications (ex: phototoxic reaction (yes/no), urgent re-bronchoscopy (yes/no))
Measured: up to 3 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pinnacle Biologics Inc.
- Responsible party
- Principal investigator, Patrick Ross, Main Line Health
- Investigators
- Patrick Ross, MD, PhD, Principal investigator, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842555
- Sponsor's protocol ID
- R16-3560
- Acronym
- PDT Registry
- Status last verified
- Aug 2018
- First submitted
- 18 Apr 2013
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy (PDT) Oncology Registry
- ClinicalTrials.gov ID
- NCT01842555
- Acronym / sponsor ID
- PDT Registry / R16-3560
- Conditions
- Lung Cancer, Esophageal
- Keywords
- PDT, Photodynamic therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Collaborators
- Pinnacle Biologics Inc.
- Study start
- Nov 2012
- Primary completion
- Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 29 Apr 2013 (estimated)
- 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.
The data elements for the PDT Registry project include virtually all the elements in the standard hospital-based cancer registry record, although in some cases at a finer level of detail. All data points should be found in the participant's medical record. The principal difference between the PDT Registry data set and that collected by the registries is the inclusion of more information specific to PDT.
Detailed description
Participating centers will need to describe its own mechanism for patient identification and eligibility screening. A data manager, identified by the Principal Investigator at each participating center, will screen all patients for eligibility. Appointment, diagnosis and treatment data will be reviewed using information such as clinic records, appointment lists, pathology department records, OR schedule and/or tumor registries. Patients meeting inclusion criteria will be enrolled in the 3-year registry which will comprise retrospective and prospective parts. Patients will be accrued retrospectively for the first 12-month period of the registry. The retrospective part will include patients who received PDT with Photofrin® from 2007 up to 2012. Patients who are eligible but die prior to enrollment will also be included to minimize bias resulting from non-inclusion of advanced stage patients. The prospective recruitment parts will be three years. The estimated length of follow-up for each patient will be 3 years. Follow-up will be conducted by research study staff at each institution via medical record review, under the direction of the Principal Investigator at that site. No patients will be contacted at any point to obtain study data or for follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDT registry patients | – | Other: RegistryAny newly diagnosed lung or esophageal cancer that is being being treated with PDT at a participating institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each participating center will need to describe its own mechanism for patient identification and eligibility screening.
Key inclusion criteria (5 listed)
- 18 years of age or older, male or female, diagnosed with cancer and is undergoing or has undergone Photodynamic Therapy (PDT).
- Patients must have undergone PDT with Photofrin® at a participating institution.
- Patients scheduled to undergo PDT with Photofrin®
- Cancer patients receiving some or all primary care (e.g.,cancer-directed surgery, systemic therapy, radiation therapy, palliative care)in the participating institution.
- Cancer patients with a history of any type of cancer who have been no evidence of disease(for five years but without a history of distant metastases or evidence of relapse if they meet the previous criteria).
Key exclusion criteria (3 listed)
- Cancer patients who present to the participating institution with a diagnosis of a simultaneous second primary.
- Cancer patients receiving all primary cancer care (e.g., cancer-directed surgery, chemotherapy, targeted therapy, radiation therapy, palliative care) outside of participating institution.
- Patients treated with photosensitizers other than Photofrin®
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 |
|---|---|---|
| RegistryAlso: PDTRegistry | Other | PDT registry patients |
Primary outcome
A Photodynamic Therapy (PDT) research repository and de-identified registry
Time frame: Up to 3 years
Participating sites will be able to utilize aggregate, de-identified data to perform research on PDT, the patients receiving PDT, and their outcomes and complications after the procedure. Data collected includes the following: Table 1. Outline of Data Elements in the PDT Registry 1. Patient Visit Form- Demographics Patient Identification Number Institution Number Study Type Surgeon ID Date of Birth Age at PDT Racial Background Gender Tobacco Use Alcohol Use Vital Status 2. Pre-Treatment Primary Site Clinical Sta
3 secondary outcomes
Survival following palliative and non-palliative PDT
Time frame: Up to 3 years
Short and long term efficacy of PDT in presenting symptom improvement
Time frame: Up to 3 years
Complications after PDT
Time frame: up to 3 years after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Main Line Healthcare SystemLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Patsy Skabla, PA contact
Patrick Ross, MD, PhD principal investigator
Main Line Health
1 site 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 and Esophageal, run by Main Line Health at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patsy Skabla, PA (SkablaP@mlhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Photodynamic Therapy (PDT) research repository and de-identified registry (time frame: Up to 3 years). 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 Aug 2018.