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

NCT06050278 | Recruiting

• 1 other identifier: TAP-NSCLC
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Tapestri success rate

  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.

  6 months

Interventions

Tapestry technology OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects older than 18 years old, male and female, with histological diagnosis of NSCLC technically operable following multisciplinary discussion.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples obtained from surgical treatment

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 22, 2023
• Study Start: April 3, 2023
• Primary Completion: August 1, 2024
• Study Completion: April 1, 2026
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After publication
• Access Criteria: Upon request

Locations

IT (1)