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

Sponsor

University of Milano Bicocca (Other)

Overall Status

Recruiting

CT.gov ID

NCT06050278

Collaborator

(none)

Enrollment

Location

35.9

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Other: Tapestry technology

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, woulb bring two benefits:

prioritize the molecular targets
identify evolutionary trajectories associated with the outcome of therapies and survival, useful to stratify patients considering the likelihood and the duration of response

Inclusion criteria are:

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

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), no statistical analyzes will be performed. Results will be presented thorugh narrative reports for each patients.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 3, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Apr 1, 2026

Outcome Measures

Primary Outcome Measures

Tapestri success rate [6 months]
Evaluation 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS San Gerardo dei Tintori	Monza	MB	Italy	20900

Sponsors and Collaborators

University of Milano Bicocca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Milano Bicocca

ClinicalTrials.gov Identifier:

NCT06050278

Other Study ID Numbers:

TAP-NSCLC

First Posted:

Sep 22, 2023

Last Update Posted:

Sep 22, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Sep 22, 2023