The Lymphocytic Infiltrate of Lung Tumors.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Immune System. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Biological Observational Monocentric Study Aimed at Analyzing the Lymphocytic Infiltrate of Lung Tumors
Overview
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.
Primary outcome measures
- LYMPHOCYTE ISOLATION [Time frame: from enrollment in the study to surgery at 15 days]
Secondary outcome measures (1)
- Lymphocyte gene expression [Time frame: from surgery to processing within 48 hours]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Scientific Institute Ospedale San Raffaele — Milan
Identifiers
NCT: NCT06470607 · 117/INT/2022