Prospective Evaluation of Single Cell Mutations in a Panel of Known Oncogenes in NSCLC Surgical Specimens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-03

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Tapestry technology

The study involves the immediate freezing and preservation in liquid nitrogen of a tumor histological sample from surgical resection, obtained from the operating room, within one hour of removal. Surgery is part of the normal clinical practice of patients with lung cancer.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Diego Cortinovis, MD

Role: primary

Elisa Sala, PhD

Role: backup

Other Identifiers

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TAP-NSCLC

Identifier Type: -

Identifier Source: org_study_id