ClinicalTrials.gg
RecruitingNCT06470607TREGILCUpdated Nov 29, 2024

The Lymphocytic Infiltrate of Lung Tumors.

An observational study in Lung Cancer and Immune System, sponsored by Scientific Institute San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Scientific Institute San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer
  • Immune System

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Keywords

  • thoracic tumors
  • Immune checkpoints
  • lymphocytes
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 70 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Scientific Institute San Raffaele is the lead sponsor of 29 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous chemotherapy for any cancer within the last 6 months;
  • Pregnant and/or breastfeeding women;
  • state (states of immunosuppression or ongoing immunosuppressive/immunomodulatory treatments)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. LYMPHOCYTE ISOLATION

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

    Time frame: from enrollment in the study to surgery at 15 days

Secondary outcomes

  1. Lymphocyte gene expression

    Analysis of gene expression and translational activity of lymphocyte cells (CD4+)

    Time frame: from surgery to processing within 48 hours

07

Study locations

1 of 1 sites recruiting
  • Scientific Institute Ospedale San Raffaele
    Milan, 20132, Italy
    Recruiting
    • Pierluigi Novellis, MD · Contact+39022643
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Jan 2026, 36 months after the start.

Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's planned 36 months is below that.

Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2024
First posted
Jun 24, 2024
StartActual
Jan 20, 2023
Primary completionEst.
Jan 20, 2026
CompletionEst.
Jan 31, 2028
Last update
Nov 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06470607
Lead sponsor
Scientific Institute San Raffaele
Responsible party
Pierluigi Novellis (MD, Scientific Institute San Raffaele) — Principal investigator
First posted
Jun 24, 2024
Start date
Jan 20, 2023
Primary completion
Jan 20, 2026 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Nov 29, 2024

Study contacts

Pierluigi Novellis, MD
Contact
novellis.pierluigi@hsr.it
+39022643 ext. 7202

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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