Lung CancerTREGILCNCT06470607
The Lymphocytic Infiltrate of Lung Tumors.
An observational study of Lung Cancer and Immune System, run by Scientific Institute San Raffaele at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Immune System
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2023to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population is made up of patients diagnosed with thoracic cancer, candidates for surgical resection for the disease.
Who may be able to join
- Ability to provide informed consent;
- Men and women over the age of 18;
- Patients candidates for surgical treatment diagnosed with thoracic tumors
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute Ospedale San Raffaele
Milan, 20132
Pierluigi Novellis, MD, +39022643 ext. 7202
About this study
Official title: Biological Observational Monocentric Study Aimed at Analyzing the Lymphocytic Infiltrate of Lung Tumors
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.
- Conditions
- Lung Cancer, Immune System
- Keywords
- thoracic tumors, Immune checkpoints, lymphocytes
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
LYMPHOCYTE ISOLATION
the collection of lymphocytes, and their sequencing and analysis of differentially expressed genes.
Measured: 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+)
Measured: from surgery to processing within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start20 Jan 2023
- Primary completion20 Jan 2026 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierluigi Novellis, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470607
- Sponsor's protocol ID
- 117/INT/2022
- Acronym
- TREGILC
- Status last verified
- Nov 2024
- First submitted
- 17 Jun 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Observational Monocentric Study Aimed at Analyzing the Lymphocytic Infiltrate of Lung Tumors
- ClinicalTrials.gov ID
- NCT06470607
- Acronym / sponsor ID
- TREGILC / 117/INT/2022
- Conditions
- Lung Cancer, Immune System
- Keywords
- thoracic tumors, Immune checkpoints, lymphocytes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is made up of patients diagnosed with thoracic cancer, candidates for surgical resection for the disease.
Key inclusion criteria (3 listed)
- Ability to provide informed consent;
- Men and women over the age of 18;
- Patients candidates for surgical treatment diagnosed with thoracic tumors
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Lymphocyte gene expression
Time frame: from surgery to processing within 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Immune System, run by Scientific Institute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierluigi Novellis, MD (+39022643 ext. 7202, novellis.pierluigi@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LYMPHOCYTE ISOLATION (time frame: from enrollment in the study to surgery at 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.