Prospective Evaluation of Single Cell Mutations in a Panel of Known Oncogenes in NSCLC Surgical Specimens (TAP-NSCLC)

University of Milano Bicocca

Status: Enrolling

Conditions: NSCLC

Treatments: Other: Tapestry technology

Study type: Observational

Funder types: Other

Identifiers

NCT06050278

TAP-NSCLC

Details and patient eligibility

About

The goal of this observational study is to evaluate the feasibility of a single cell mutation research method in a panel of known oncogenes, using the Tapestri method. Tissue samples will be obtained after surgical treatment in patients with I-II-III stage NSCLC.

Full description

NSCLC is a particularly heterogeneous disease with different genetic alterations in oncogenes 'drivers', responsible for the development and progression of the disease. In most cases all these anomalies represent clonal mutations in all neoplastic cells. However, several sub-clonal genetic alterations were identified in some multi-regional sequencing studies, demonstrating an intra-tumor heterogeneity. Tracing the clonal architecture of the disease and also the temporal order of the various mutations appearance, would bring two benefits:

1. prioritize the molecular targets
2. identify evolutionary trajectories associated with the outcome of therapies and survival, useful to stratify patients considering the likelihood and the duration of response For the bioinformatic data analyses will be used the Tapestri MissionBio pipeline.

Given the limited number of patients that can be included in the study (10 patients), no statistical analyzes will be performed. Results will be presented thorugh narrative reports for each patients.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18 years old.
• histological diagnosis of NSCLC technically operable following multidisciplinary discussion
• informed consent freely granted and obtained before the start of the study

Exclusion criteria

• age under 18 years old
• unconfirmed NSCLC histological diagnosis
• medical treatment with neoadjuvant purposes
• absence of informed consent