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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06050278
Acronym
TAP-NSCLC
Enrollment
10
Registered
2023-09-22
Start date
2023-04-03
Completion date
2026-04-30
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Brief summary

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

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.

Interventions

OTHERTapestry 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.

Sponsors

University of Milano Bicocca
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tapestri success rate6 monthsEvaluation of the feasibility of a single cell mutation search method in a panel of known oncogenes, using Tapestri technology, in tumor tissue obtained from stage I-II-III NSCLC patients after surgical treatment planned in clinical practice.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026