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

Neoplastic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02159742
• Other study ID #: UPCC 06911
• Status: Active, not recruiting
• Start date: July 2011
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Neoplasms
• Neoplastic Disease

Intervention

Other:
• Data Collection

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival and disease free		10 years