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Clinical Trials: Cancer - Rare
IRB No. 25-374-1 (Dr. John Birk, PI): Using Automated Biochips to Assist in Specific Chemotherapy Selection in Pancreatic Cancer Patients
This research study is evaluating a new laboratory technology called the Encapsulate Biochip, which is designed to test how tumor cells, such as those from pancreatic cancer, respond to different chemotherapy drugs. The goal of this research is to explore whether this technology could eventually help doctors select more personalized and effective treatments for cancer patients. Participants in this study will be individuals who are already scheduled to undergo a standard diagnostic procedure called endoscopic ultrasound with fine-needle aspiration (EUS-FNA) at UConn Health as part of their routine evaluation for possible pancreatic cancer. If enough tissue is collected for diagnostic purposes during the EUS-FNA, a small additional biopsy sample will be taken at the same time for research purposes. This extra sample will not affect clinical care or the diagnosis. It will be de-identified (coded) and sent to the Encapsulate laboratory for testing using the Biochip system. There are no extra visits or procedures required as part of this study beyond what the patient would already undergo for their medical care. After the EUS-FNA procedure, the participants will continue to follow up with their treating physician/oncologist per standard care, and the clinical study investigators will review the participants' medical records over the following 3 to 6 months to gather information about their diagnosis, treatment plan, and outcomes. This study is considered to pose only a slight increase over minimal risk, as it involves no significant additional procedures beyond those already associated with the participant';s standard-of-care EUS-FNA. The additional research biopsy collected during the EUS-FNA procedure is small in size and only obtained after adequate tissue has been secured for diagnostic purposes. As such, the added risk to participants is minimal and primarily limited to a possible slight increase in procedure time and the theoretical risk of complications related to the extra biopsy sample.