The Lymphocytic Infiltrate of Lung Tumors.

NCT06470607 | Recruiting

• 1 other identifier: 117/INT/2022
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Immune System

Keywords

thoracic tumors; Immune checkpoints; lymphocytes

Outcome Measures

Primary Outcomes (1)

• LYMPHOCYTE ISOLATION

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

  from enrollment in the study to surgery at 15 days

Secondary Outcomes (1)

• Lymphocyte gene expression

  from surgery to processing within 48 hours

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

Scientific Institute Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples include: peripheral blood and tumor tissue. The following will be analyzed: Number of infiltrating lymphocytes; expression of markers of the immune response,

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Pierluigi Novellis, MD

CONTACT

+39022643; novellis.pierluigi@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: January 20, 2023
• Primary Completion: January 20, 2026
• Study Completion (Estimated): January 31, 2028
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

IT (1)