Neoplastic DiseaseNCT02159742
Prospective Follow-up of Outcomes in Patients Receiving Photodynamic Therapy for Neoplastic Diseases
An observational study of Neoplastic Disease, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
From 1996-present, we have used photodynamic therapy (PDT) to treat a number of neoplastic diseases both on prospective research protocols (for head and neck cancer, pleural malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for FDA approved and off label or compassionate exemption… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplastic Disease
- What is being tested?
- Data Collection
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Prospective/retrospective data will be collected from medical records of patients who have received PDT for neoplastic diseases.
Who may be able to join
- Subjects will be age 18 or greater
- Subjects will have undergone PDT for a diagnosis of neoplastic disease under the direction of a Penn physician.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
From 1996-present, we have used photodynamic therapy (PDT) to treat a number of neoplastic diseases both on prospective research protocols (for head and neck cancer, pleural malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for FDA approved and off label or compassionate exemption indications (neoplasms of the skin, bronchus, esophagus, head and neck and pleura). The goal of this treatment is to maximize quality of life and organ function while minimizing the chance of tumor recurrence. As such, we would like to retrospectively review the treatment parameters of all patients who undergo/underwent PDT (including operative notes and photodynamic therapy records) and treatment outcomes (including all organ functions, performance status, tumor recurrence, laboratory values and any other data present in the routinely documented follow up visits). For patients who have died or were lost to follow-up prior to initiation of this study, a retrospective review of available data will be performed. For patients who are still being actively followed after PDT or who receive PDT after the initiation of this study, informed consent will be obtained for obtaining continued follow-up data prospectively and any previous data will be collected retrospectively.. These subjects will continue to receive care from their current physicians according to standard medical practice and no attempt will be made to alter the types of follow-up, radiologic or other diagnostic studies or medical treatment as a result of enrollment in this study. All data will be de-identified and added to our already existing PDT treatment outcome databases for outcomes analysis, quality improvement and reporting of results in abstract and manuscript forms.
- Conditions
- Neoplastic Disease
- Being tested
- Data Collection
- Keywords
- Adult subjects, history, treatment, photodynamic therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Also called Prospective/retrospective data will be collected from medical records of patients who have received PDT for, neoplastic diseases.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Not described Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival and disease free
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplastic DiseaseStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Cengel, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159742
- Sponsor's protocol ID
- UPCC 06911
- Status last verified
- Jul 2026
- First submitted
- 6 Jun 2014
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-up of Outcomes in Patients Receiving Photodynamic Therapy for Neoplastic Diseases
- ClinicalTrials.gov ID
- NCT02159742
- Acronym / sponsor ID
- UPCC 06911
- Conditions
- Neoplastic Disease
- Keywords
- Adult subjects, history, treatment, photodynamic therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jun 2014 (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.
From 1996-present, we have used photodynamic therapy (PDT) to treat a number of neoplastic diseases both on prospective research protocols (for head and neck cancer, pleural malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for FDA approved and off label or compassionate exemption indications (neoplasms of the skin, bronchus, esophagus, head and neck and pleura). The goal of this treatment is to maximize quality of life and organ function while minimizing the chance of tumor recurrence. As such, we would like to retrospectively review the treatment parameters of all patients who undergo/underwent PDT (including operative notes and photodynamic therapy records) and treatment outcomes (including all organ functions, performance status, tumor recurrence, laboratory values and any other data present in the routinely documented follow up visits). For patients who have died or were lost to follow-up prior to initiation of this study, a retrospective review of available data will be performed. For patients who are still being actively followed after PDT or who receive PDT after the initiation of this study, informed consent will be obtained for obtaining continued follow-up data prospectively and any previous data will be collected retrospectively.. These subjects will continue to receive care from their current physicians according to standard medical practice and no attempt will be made to alter the types of follow-up, radiologic or other diagnostic studies or medical treatment as a result of enrollment in this study. All data will be de-identified and added to our already existing PDT treatment outcome databases for outcomes analysis, quality improvement and reporting of results in abstract and manuscript forms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Data Collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective/retrospective data will be collected from medical records of patients who have received PDT for neoplastic diseases.
Key inclusion criteria (2 listed)
- Subjects will be age 18 or greater
- Subjects will have undergone PDT for a diagnosis of neoplastic disease under the direction of a Penn physician.
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 |
|---|---|---|
| Data CollectionAlso: Prospective/retrospective data will be collected from medical records of patients who have received PDT for, neoplastic diseases. | Other | Cohort 1 |
Primary outcome
Survival and disease free
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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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.
Keith Cengel, MD principal investigator
Abramson Cancer Center at Penn Medicine
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 Neoplastic Disease, run by Abramson Cancer Center at Penn Medicine 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 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Survival and disease free (time frame: 10 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 8 Jul 2026.