The Lymphocytic Infiltrate of Lung Tumors. (TREGILC)

November 26, 2024 updated by: Pierluigi Novellis, Scientific Institute San Raffaele

Biological Observational Monocentric Study Aimed at Analyzing 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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • Scientific Institute Ospedale San Raffaele
        • Contact:
          • Pierluigi Novellis, MD
          • Phone Number: 7202 +39022643

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population is made up of patients diagnosed with thoracic cancer, candidates for surgical resection for the disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from enrollment in the study to surgery at 15 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scientific Institute San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Estimated)

January 20, 2026

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 117/INT/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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