Non Small Cell Lung CancerNCT06331975
Radiomics and Radiogenomics of Non-small Cell Lung Cancer
A study testing Radiomic signature in people with Non Small Cell Lung Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Radiomic signature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2018to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- patients with diagnosis of NSCLC
- patients candidates for mutational status assessment
Who cannot join
- patients with age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiomics and Radiogenomics of Non-small Cell Lung Cancer: Relationships of Radiomic Signature With Gene Driver Mutations and Implications for Emerging Therapies
In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up
Read the detailed description
Non-small cell lung cancers (NSCLC) are the first cause of cancer-related deaths.
Recent guidelines suggest the key role of a wide molecular profile because knowledge of the tumor genotype can enable patients with NSCLC to be treated with targeted therapies.
In this study, a first group of patients with lung adenocarcinoma (study group), tested for the presence of genetic alterations in EGFR, ALK, and KRAS, and with available Computer Tomography (CT) scans, will be evaluated to create a radiomic signature and assess its association with mutational status and prognosis.
Then, a second group of patients (validation group) will be enrolled to validate the radiomic signature and the status of the genetic alterations and their association with prognosis. Radiomic signature and liquid biopsies will be evaluated in patients positive for genetic alterations at each follow-up step to verify their association with prognosis and response to targeted therapies.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Radiomic signature
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomic signatureDiagnostic test
Assessment of radiomic signature and tumor genetic profile in patients with Non Small Cell Lung Cancer (NSCLC)
| Study group | Role | What they receive |
|---|---|---|
| Radiomic signature | Other | Assessment of radiomic signature and tumor genetic profile at baseline Receives: Diagnostic Test: Radiomic signature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status
The status of EGFR, ALK, KRAS will be validated for its association with nodal status at surgery
Measured: 1 month
Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS)
Number of patiens with EGFR, ALK, KRAS mutations alive at five years
Measured: 5 years
Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS)
Number of patiens with EGFR, ALK, KRAS mutations with an oncological event (local or distant) during follow up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start12 Jun 2018
- Primary completion31 Jan 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Botta, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331975
- Sponsor's protocol ID
- IEO 0836
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ranghiero A, Rinaldi L, Netti S, Gaeta A, Attili I, Spitaleri G, Funicelli G, Mora S, Fodor C, Origgi DA, De Marinis F, Fusco N, Rizzo S, Barberis M, Raimondi S, Botta F, Gandini S, Guerini-Rocco E. Radiogenomic approach combining CT-based radiomics and liquid biopsy improves prognostic stratification in patients with advanced NSCLC. J Liq Biopsy. 2026 Apr 26;12:100470. doi: 10.1016/j.jlb.2026.100470. eCollection 2026 Jun.
PubMed 42095156
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics and Radiogenomics of Non-small Cell Lung Cancer: Relationships of Radiomic Signature With Gene Driver Mutations and Implications for Emerging Therapies
- ClinicalTrials.gov ID
- NCT06331975
- Acronym / sponsor ID
- IEO 0836
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 26 Mar 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.
In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up
Detailed description
Non-small cell lung cancers (NSCLC) are the first cause of cancer-related deaths.
Recent guidelines suggest the key role of a wide molecular profile because knowledge of the tumor genotype can enable patients with NSCLC to be treated with targeted therapies.
In this study, a first group of patients with lung adenocarcinoma (study group), tested for the presence of genetic alterations in EGFR, ALK, and KRAS, and with available Computer Tomography (CT) scans, will be evaluated to create a radiomic signature and assess its association with mutational status and prognosis.
Then, a second group of patients (validation group) will be enrolled to validate the radiomic signature and the status of the genetic alterations and their association with prognosis. Radiomic signature and liquid biopsies will be evaluated in patients positive for genetic alterations at each follow-up step to verify their association with prognosis and response to targeted therapies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiomic signature | Other | Diagnostic Test: Radiomic signatureAssessment of radiomic signature and tumor genetic profile at baseline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with diagnosis of NSCLC
- patients candidates for mutational status assessment
Key exclusion criteria (1 listed)
- patients with age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiomic signatureAssessment of radiomic signature and tumor genetic profile in patients with Non Small Cell Lung Cancer (NSCLC) | Diagnostic test | Radiomic signature |
Primary outcome
Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status
Time frame: 1 month
The status of EGFR, ALK, KRAS will be validated for its association with nodal status at surgery
Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS)
Time frame: 5 years
Number of patiens with EGFR, ALK, KRAS mutations alive at five years
Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS)
Time frame: 5 years
Number of patiens with EGFR, ALK, KRAS mutations with an oncological event (local or distant) during follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 42095156Ranghiero A, Rinaldi L, Netti S, Gaeta A, Attili I, Spitaleri G, Funicelli G, Mora S, Fodor C, Origgi DA, De Marinis F, Fusco N, Rizzo S, Barberis M, Raimondi S, Botta F, Gandini S, Guerini-Rocco E. Radiogenomic approach combining CT-based radiomics and liquid biopsy improves prognostic stratification in patients with advanced NSCLC. J Liq Biopsy. 2026 Apr 26;12:100470. doi: 10.1016/j.jlb.2026.100470. eCollection 2026 Jun.
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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. This study is not recruiting at the moment.
Francesca Botta principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiomic signature in people with Non Small Cell Lung Cancer, run by European Institute of Oncology 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 26 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06331975, which also lists 1 linked publication.
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 26 Mar 2024.