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NCT Number: NCT06470607

The Lymphocytic Infiltrate of Lung Tumors.

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.

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Key information

Conditions

Lung Cancer Immune System Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scientific Institute Ospedale San Raffaele

Milan, 20132, Italy

Location status: Recruiting

Location contact

Pierluigi Novellis, MD

CONTACT

+39022643 ext. 7202

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. LYMPHOCYTE ISOLATION

    Time frame: from enrollment in the study to surgery at 15 days

    the collection of lymphocytes, and their sequencing and analysis of differentially expressed genes.

Secondary outcomes

  1. Lymphocyte gene expression

    Time frame: from surgery to processing within 48 hours

    Analysis of gene expression and translational activity of lymphocyte cells (CD4+)

Study contacts

Contact information is provided by the study sponsor or research team.

Pierluigi Novellis, MD

CONTACT

[email protected]

+39022643 ext. 7202

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Registry information

Official study title

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

Acronym: TREGILC

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jun 24, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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