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Protocol No. UW17049
Principal Investigator LoConte, Noelle
Age Group Adult
Sponsor Type Industry
Title Long Term Follow-Up Study for Subjects Previously Treated with Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy
Objective The purpose of this clinical study is to determine if there are any long term safety risks for those subjects who have received the algenpantucel-L immunotherapy. Only subjects who have previously received the algenpantucel-L in clinical trials will be invited to participate in this long term follow up study.
Treatment During years 1-5 you will be asked to come to the clinic for a visit at least once a year for the first five years. You will be asked questions about medical history, physical exam will be completed, a small amount of blood will be collected, and asked if your contact information has changed. During years 6-15, you will be called on the phone or sent a questionnaire in the mail at least once/year.
Description If any of the tests that are performed in this study suggest that you may have a medical condition and/or side effect that is likely to be related to the algenpantucel-L, the study doctor will contact you. You will be asked to provide another small sample of blood (approximately 1 teaspoon) to be tested for presence of the retrovirus used in making the algenpantucel-L immunotherapy. You will also receive a referral in case you would like to seek medical care for the condition and/or side effect.
- Subjects who have received at least one dose of algenpantucel-L (HyperAcute-Pancreas) in a previous clinical trial
- Subjects who have provided written informed consent for the long-term follow-up study prior to study participation
Applicable Disease Sites Pancreas
Drugs Involved Not Applicable
Participating Institutions UW Hospital and Clinics