ENIGMA+: a national, decentralized, remote consent study for clinical data and biospecimen collection in patients with ALK-positive advanced NSCLC.

ABSTRACT:

Objective

Despite advances in ALK inhibitors for ALK fusion-positive (ALK+) non-small-cell lung cancer (NSCLC), drug resistance remains a challenge. Studies of treatment outcomes and resistance biomarkers are imperative for drug development, yet patient representation can be limited. This study evaluated the feasibility of a decentralized research infrastructure to establish a clinical and biospecimen repository, broadening patient access and inclusion.

Patients and methods

Patients with advanced ALK+ NSCLC across the United States were enrolled through remote informed consent. Clinical history and tumor molecular profiling data were collected at baseline and during remote follow-ups. Archival tumor and saliva biospecimens (for germline sampling) were obtained for analysis.<

SUBMITTER: Liang J 

PROVIDER: S-EPMC12404294 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature