The Lymphocytic Infiltrate of Lung Tumors.

Recruiting

• Conditions: Lung Cancer; Immune System

• Registration Number: NCT06470607
• Lead Sponsor: Scientific Institute San Raffaele

Brief Summary

The study is configured as a monocentric observational transversal biological study.

The main objective of the study is the reconstruction of the molecular organization of tumors of the thoracic cavity, in particular non-small cell lung cancer (NSCLC).

The study involves the collection of clinical data and biological material (blood and tumor tissue) from 70 subjects diagnosed with thoracic tumors.

Detailed Description

Inclusion criteria:

The study population will include all patients with the following characteristics:

* Ability to provide informed consent

* Men and women over the age of 18 years old

* Patients candidates for surgical treatment diagnosed with thoracic tumors

The procedures to which the patient will undergo during the study follow the standard of clinical practice for the treatment of pathology.

Exclusion criteria:

* Previous chemotherapy for any cancer within the last 6 months

* Pregnant and/or breastfeeding women

* Immunosuppressive state (states of immunosuppression or ongoing immunosuppressive/immunomodulatory treatments)

The time of observation of the patient for the purposes of the study is limited to the time of hospitalization and the surgical procedure, the patient will therefore perform a single visit to the hospital and there is no provision for the collection of further data following discharge. The study involves a single timepoint of data collection and samples.

The study will have a total duration of 3 years.

Study Timeline

• Study Start: 2023-01-20
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2026-01-20
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Ability to provide informed consent;
• Men and women over the age of 18;
• Patients candidates for surgical treatment diagnosed with thoracic tumors

Exclusion Criteria

• Previous chemotherapy for any cancer within the last 6 months;
• Pregnant and/or breastfeeding women;
• Immunosuppressive state (states of immunosuppression or ongoing immunosuppressive/immunomodulatory treatments)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LYMPHOCYTE ISOLATION	from enrollment in the study to surgery at 15 days	the collection of lymphocytes, and their sequencing and analysis of differentially expressed genes.

Secondary Outcome Measures

Name	Time	Method
Lymphocyte gene expression	from surgery to processing within 48 hours	Analysis of gene expression and translational activity of lymphocyte cells (CD4+)

Trial Locations

Locations (1)

Scientific Institute Ospedale San Raffaele; 🇮🇹 Milan, Italy