The Lymphocytic Infiltrate of Lung Tumors.

NCT ID: NCT06470607

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-20

Study Completion Date

2028-01-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer Immune System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Pierluigi Novellis

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Scientific Institute Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pierluigi Novellis, MD

Role: CONTACT

+39022643 ext. 7202

Facility Contacts

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Pierluigi Novellis, MD

Role: primary

+39022643 ext. 7202

Other Identifiers

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117/INT/2022

Identifier Type: -

Identifier Source: org_study_id