Safety of oral mucosal punch biopsy and other oral biospecimen collections in clinical research.

Objective: Oral punch biopsies are frequently used for analysis of lesions since they are minimally invasive, easily performed, and assist in diagnosis. Despite broad usage, recent changes in risk classification characterize oral punch biopsies as "greater than minimal risk" for institutional review board purposes. We performed a retrospective review of oral sampling in clinical trials to determine the safety of punch biopsies and other biospecimen collection methods in our oral cancer surveillance program.

Study design: Punch biopsies of 3- and 4-mm were collected following topical and local injection anesthetic. Hemostasis was achieved using pressure and silver nitrate cautery. Other specimens were collected according to standard collection guidelines. Safety and adverse events were determined through consultation with clinical investigator guidelines and were graded with the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.

Results: In total, 579 samples were collected, 339 of which were oral punch biopsies. There were no adverse events above NCI CTCAE grade 1 for any biospecimen collection.

Conclusions: These results support the safety profile of oral punch biopsies and saliva collection. Additionally, these results align with previous research on punch biopsy safety and demonstrate fewer bleeding events. Based on the results and prior research, we believe that punch biopsies should be considered a minimal-risk procedure.