Prospective Follow-up of Outcomes in Patients Receiving Photodynamic Therapy for Neoplastic Diseases

NCT02159742 | Active Not Recruiting DMC

• 1 other identifier: UPCC 06911
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Adult subjects; history; treatment; photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Survival and disease free

  10 years

Study Arms (1)

Cohort 1

Other: Data Collection

Interventions

Data Collection OTHER

Also known as: Prospective/retrospective data will be collected from medical records of patients who have received PDT for, neoplastic diseases.

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective/retrospective data will be collected from medical records of patients who have received PDT for neoplastic diseases.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Data Collection; Longitudinal Studies

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics

Study Officials

• Keith Cengel, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 10, 2014
• Study Start: July 1, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

US (1)