Feasibility, safety, and adequacy of research biopsies for cancer clinical trials at an academic medical center.

ABSTRACT:

Objective

Research biopsies are an essential component of cancer clinical trials for studying drug efficacy and identifying biomarkers. Site-level clinical investigators, however, do not have access to results on the adequacy of research biopsies for histological or molecular assays, because samples are sent to central labs and the test results are seldom reported back to site-level investigators unless requested. We evaluated the feasibility, safety, and adequacy of research biopsies performed at an academic medical center.

Materials and methods

We retrospectively reviewed the data on 122 research biopsy sessions conducted in 99 patients via percutaneous core needle biopsy for 39 clinical trials from January 2017 to February 2018 at a single institute. We asked the sponsors

SUBMITTER: Lee K 

PROVIDER: S-EPMC6690517 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature