Biological Observational Monocentric Study Aimed at Analyzing the Lymphocytic Infiltrate of Lung Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- LYMPHOCYTE ISOLATION
Study Overview
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
- Lymphocyte gene expression(from surgery to processing within 48 hours)
Investigators
Pierluigi Novellis
MD
Scientific Institute San Raffaele