Lung Neoplasm MalignantMONDRIANNCT05974475
MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
An observational study of Lung Neoplasm Malignant, run by European Institute of Oncology at 2 sites in Italy.
Trial summary
Stereotactic Body Radiotherapy (SBRT) is a form of high-precision radiotherapy playing a major role in patients diagnosed with early-stage non-small cell lung cancer (NSLCL), especially when surgery cannot be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- SBRT and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 2 sitesItaly
- Study dates
- 11 Sep 2023to Sep 2028
- How long will I take part?
- 24 Months
- 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: Tertiary care cancer center, early-stage NSCLC.
Who may be able to join
- Histologically proven NSCLC; all histologies will be considered eligible (e.g. squamous, adenocarcinoma, large cell carcinoma);
- American Joint Committee on Cancer Tumor Node Metastasis (AJCC TNM) classification (8th Edition) clinical stage I-II;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- No absolute contraindications to either surgery (e.g. severe comorbidities) or SBRT (e.g. active connective diseases, severe pulmonary fibrosis);
- Ability and willingness to sign a written informed consent for treatment and study participation.
Who cannot join
- Prior diagnosis of invasive cancer (within 3 years before the diagnosis of ES-NSCLC);
- Mental diseases or psychiatric disorders preventing the acquisition of a valid informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, Italy, 20141
Stefania Volpe, MD, +390257489037, stefania.volpe@ieo.it
- Recruiting
Istituto Europeo di Oncologia (IEO) IRCCS
Milan, Lombardy, 20141
Stefania Volpe, MD, stefania.volpe@ieo.it
Cristiana I Fodor, MSc, cristiana.fodor@ieo.it
About this study
Stereotactic Body Radiotherapy (SBRT) is a form of high-precision radiotherapy playing a major role in patients diagnosed with early-stage non-small cell lung cancer (NSLCL), especially when surgery cannot be performed. It is a non-invasive, well-tolerated treatment, with an excellent ability to control disease recurrence. However, in some patients, disease response is suboptimal: understanding why this happens may open doors to more aggressive approaches, such as the combination with systemic therapies.
Hence, the goal of this observational trial is to understand which clinical, imaging, and biological factors are associated with response to SBRT through the development of complex models. In other words, the main question it aims to answer is: "Will this patient respond to radiation treatment based on the characteristics of their disease?".
Read more
Participants will be treated according to the best clinical practice standards, in agreement with international, national, and internal guidelines.
Researchers will compare data collected from patients treated with SBRT with those collected from a similar group of patients, who will be treated with surgery, to see which factors are actual predictors of response to SBRT, or rather are indicators of more or less aggressive disease behavior.
Read the detailed description
The overall planned duration of the study is 60 months.
The project is structured into five main tasks, as following:
- Task 1_Clinical study: Routine clinical data will be collected from eligible patients, including demographics, disease and treatment characteristics, pulmonary function, and blood count parameters.
- Task 2_Radiomics study: Quantitative imaging analysis will be performed on both diagnostic computed tomographies (CTs) and positron emission tomographies (PETs). A software compliant with the Imaging Biomarker Standardization Initiative (IBSI) will be used to extract radiomic features at baseline and at the first clinical progression (or at the last available follow-up, whichever comes first). Clinically established qualitative and semiquantitative metrics (e.g. pleural effusion in CT images and standardized uptake value in PET images) will be retrieved, as well.
- Task 3_Gene expression study: Gene expression profiling will be performed at baseline in both cohorts to investigate the presence of a prognostic pretreatment signature. The analysis will be performed on formalin-fixed paraffin-embedded (FFPE) tissue samples (namely, resected tumor in the surgical cohort and bioptic sample- whenever available- in the SBRT group). A next-generation sequencing (NGS)-based assay which targets 395 immune-related genes and named as Oncomine™ Immune Response Research Assay, will be employed.
- Task 4_Proteomics study: Proteomics will integrate the study of RNA expression performed in Task 3. As in Task 3, the analysis will be performed on FFPE samples, from both patients' cohorts.
- Task 5_Integrative model building: Integration of all previous features in a unique classification model able to determine a precise estimate of individuals with high vs low risk of disease progression and, at the same time, identify relevant predictive factors. The proposed classification model will integrate data from different sources using a multi-layer deep neural network. Federated learning techniques will also be used to reduce the bias due to the choice of a specific trial or data source.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- SBRT, Surgery
- Keywords
- Early stage non-small cell lung cancer, Stereotactic body radiotherapy (SBRT), Radiosensitivity, Radioresistance, Multi-omics, Radiomics, Genomics, Proteomics, Outcome modeling
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called Stereotactic body radiotherapy, Stereotactic Ablative Radiotherapy (SABR)
State-of-art SBRT will be delivered in 3-5 fractions; prescription doses and fractionation schedules will be defined according to patient- and tumor-related characteristics (e.g. pulmonary comorbidities, tumor location: peripheral vs central vs ultra-central).
SurgeryProcedure or surgery
State-of-art surgery will be consist in pulmonary anatomical resection (i.e. segmentectomy or lobectomy) and systematic lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| SBRT Cohort | Radiation: Stereotactic Body Radiotherapy (SBRT) Receives: Radiation: SBRT | |
| Surgery Cohort | Procedure: Surgery Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
The time between the beginning of SBRT or date of surgery, and any disease progression (local, regional, distant), death from any cause, or last follow-up, whichever comes first.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start11 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
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 Lung Neoplasm MalignantStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Responsible party
- Sponsor
- Investigators
- Stefania Volpe, MD, Principal investigator, Istituto Europeo di Oncologia IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974475
- Sponsor's protocol ID
- R1842/23-IEO1973
- Acronym
- MONDRIAN
- Status last verified
- Sep 2024
- First submitted
- 26 Jul 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Volpe S, Zaffaroni M, Piperno G, Vincini MG, Zerella MA, Mastroleo F, Cattani F, Fodor CI, Bellerba F, Bonaldi T, Bonizzi G, Ceci F, Cremonesi M, Fusco N, Gandini S, Garibaldi C, Torre D, Noberini R, Petralia G, Spaggiari L, Venetis K, Orecchia R, Casiraghi M, Jereczek-Fossa BA. Multi-omics integrative modelling for stereotactic body radiotherapy in early-stage non-small cell lung cancer: clinical trial protocol of the MONDRIAN study. BMC Cancer. 2023 Dec 15;23(1):1236. doi: 10.1186/s12885-023-11701-9.
PubMed 38102575
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05974475
- Acronym / sponsor ID
- MONDRIAN / R1842/23-IEO1973
- Conditions
- Lung Neoplasm Malignant
- Keywords
- Early stage non-small cell lung cancer, Stereotactic body radiotherapy (SBRT), Radiosensitivity, Radioresistance, Multi-omics, Radiomics, Genomics, Proteomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Aug 2023 (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.
Stereotactic Body Radiotherapy (SBRT) is a form of high-precision radiotherapy playing a major role in patients diagnosed with early-stage non-small cell lung cancer (NSLCL), especially when surgery cannot be performed. It is a non-invasive, well-tolerated treatment, with an excellent ability to control disease recurrence. However, in some patients, disease response is suboptimal: understanding why this happens may open doors to more aggressive approaches, such as the combination with systemic therapies.
Hence, the goal of this observational trial is to understand which clinical, imaging, and biological factors are associated with response to SBRT through the development of complex models. In other words, the main question it aims to answer is: "Will this patient respond to radiation treatment based on the characteristics of their disease?".
Participants will be treated according to the best clinical practice standards, in agreement with international, national, and internal guidelines.
Researchers will compare data collected from patients treated with SBRT with those collected from a similar group of patients, who will be treated with surgery, to see which factors are actual predictors of response to SBRT, or rather are indicators of more or less aggressive disease behavior.
Detailed description
The overall planned duration of the study is 60 months.
The project is structured into five main tasks, as following:
- Task 1_Clinical study: Routine clinical data will be collected from eligible patients, including demographics, disease and treatment characteristics, pulmonary function, and blood count parameters.
- Task 2_Radiomics study: Quantitative imaging analysis will be performed on both diagnostic computed tomographies (CTs) and positron emission tomographies (PETs). A software compliant with the Imaging Biomarker Standardization Initiative (IBSI) will be used to extract radiomic features at baseline and at the first clinical progression (or at the last available follow-up, whichever comes first). Clinically established qualitative and semiquantitative metrics (e.g. pleural effusion in CT images and standardized uptake value in PET images) will be retrieved, as well.
- Task 3_Gene expression study: Gene expression profiling will be performed at baseline in both cohorts to investigate the presence of a prognostic pretreatment signature. The analysis will be performed on formalin-fixed paraffin-embedded (FFPE) tissue samples (namely, resected tumor in the surgical cohort and bioptic sample- whenever available- in the SBRT group). A next-generation sequencing (NGS)-based assay which targets 395 immune-related genes and named as Oncomine™ Immune Response Research Assay, will be employed.
- Task 4_Proteomics study: Proteomics will integrate the study of RNA expression performed in Task 3. As in Task 3, the analysis will be performed on FFPE samples, from both patients' cohorts.
- Task 5_Integrative model building: Integration of all previous features in a unique classification model able to determine a precise estimate of individuals with high vs low risk of disease progression and, at the same time, identify relevant predictive factors. The proposed classification model will integrate data from different sources using a multi-layer deep neural network. Federated learning techniques will also be used to reduce the bias due to the choice of a specific trial or data source.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT Cohort | – | Radiation: SBRTRadiation: Stereotactic Body Radiotherapy (SBRT) |
| Surgery Cohort | – | Procedure: SurgeryProcedure: Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care cancer center, early-stage NSCLC.
Key inclusion criteria (5 listed)
- Histologically proven NSCLC; all histologies will be considered eligible (e.g. squamous, adenocarcinoma, large cell carcinoma);
- American Joint Committee on Cancer Tumor Node Metastasis (AJCC TNM) classification (8th Edition) clinical stage I-II;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- No absolute contraindications to either surgery (e.g. severe comorbidities) or SBRT (e.g. active connective diseases, severe pulmonary fibrosis);
- Ability and willingness to sign a written informed consent for treatment and study participation.
Key exclusion criteria (2 listed)
- Prior diagnosis of invasive cancer (within 3 years before the diagnosis of ES-NSCLC);
- Mental diseases or psychiatric disorders preventing the acquisition of a valid informed consent.
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 |
|---|---|---|
| SBRTAlso: Stereotactic body radiotherapy, Stereotactic Ablative Radiotherapy (SABR)State-of-art SBRT will be delivered in 3-5 fractions; prescription doses and fractionation schedules will be defined according to patient- and tumor-related characteristics (e.g. pulmonary comorbidities, tumor location: peripheral vs central vs ultra-central). | Radiation | SBRT Cohort |
| SurgeryState-of-art surgery will be consist in pulmonary anatomical resection (i.e. segmentectomy or lobectomy) and systematic lymph node dissection. | Procedure or surgery | Surgery Cohort |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 24 months
The time between the beginning of SBRT or date of surgery, and any disease progression (local, regional, distant), death from any cause, or last follow-up, whichever comes first.
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 23 Sep 2024.
- Derived from this study: PubMed 38102575Volpe S, Zaffaroni M, Piperno G, Vincini MG, Zerella MA, Mastroleo F, Cattani F, Fodor CI, Bellerba F, Bonaldi T, Bonizzi G, Ceci F, Cremonesi M, Fusco N, Gandini S, Garibaldi C, Torre D, Noberini R, Petralia G, Spaggiari L, Venetis K, Orecchia R, Casiraghi M, Jereczek-Fossa BA. Multi-omics integrative modelling for stereotactic body radiotherapy in early-stage non-small cell lung cancer: clinical trial protocol of the MONDRIAN study. BMC Cancer. 2023 Dec 15;23(1):1236. doi: 10.1186/s12885-023-11701-9.
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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.
Stefania Volpe, MD principal investigator
Istituto Europeo di Oncologia IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasm Malignant, run by European Institute of Oncology at 2 sites 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 5 inclusion and 2 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Stefania Volpe, MD, PhD (0039 02 57489037, stefania.volpe@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 24 months). 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 NCT05974475, 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 23 Sep 2024.