The Lymphocytic Infiltrate of Lung Tumors.

Biological Observational Monocentric Study Aimed at Analyzing the Lymphocytic Infiltrate of Lung Tumors

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06470607

Acronym

TREGILC

Enrollment

Registered

2024-06-24

Start date

2023-01-20

Completion date

2028-01-31

Last updated

2024-11-29

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

Conditions

Immune System, Lung Cancer

Keywords

thoracic tumors, Immune checkpoints, lymphocytes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Italy

Contacts

Primary ContactPierluigi Novellis, MD

novellis.pierluigi@hsr.it+39022643

Outcome results