Multi-omics integrative modelling for stereotactic body radiotherapy in early-stage non-small cell lung cancer: clinical trial protocol of the MONDRIAN study.
Stefania Volpe, Mattia Zaffaroni, Gaia Piperno...
https://pubmed.ncbi.nlm.nih.gov/38102575Actively Recruiting
Age: 18Years +
All Genders
ID05974475
MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
Led by European Institute of Oncology · Updated on 2024-09-23
270
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
E
European Institute of Oncology
Lead Sponsor
A
Associazione Italiana per la Ricerca sul Cancro
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating early-stage non-small cell lung cancer (NSCLC), focusing on why some patients respond well to Stereotactic Body Radiotherapy (SBRT) while others do not. This observational study aims to identify clinical, imaging, and biological factors that may predict how patients will respond to SBRT. The study compares patients treated with SBRT to those treated with surgery to understand which factors indicate disease behavior and treatment response. Participants will receive either SBRT or surgery based on the best clinical practices. SBRT is a high-precision radiation treatment delivered in 3-5 sessions, with doses tailored to patient and tumor characteristics like lung health and tumor location. Surgery involves pulmonary anatomical resection and lymph node removal. Both treatment groups will contribute data for advanced analyses, including imaging, gene expression, and proteomics, to build predictive models. During the 60-month study, participants will have routine clinical data collected, including scans (CT and PET), blood tests, and tissue analysis from tumors or biopsies. Researchers will use this information to develop complex models predicting disease progression and treatment outcomes. The main outcome measured is progression-free survival over 24 months. The study also applies advanced techniques like deep neural networks and federated learning to integrate data from multiple sources and reduce bias.
CONDITIONS
Brief Title
MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically proven non-small cell lung cancer (NSCLC), any histology type
- Clinical stage I or II according to AJCC TNM classification (8th Edition)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No absolute contraindications to surgery or SBRT
- Ability and willingness to sign informed consent for treatment and study participation
You will not qualify if you...
- Prior invasive cancer diagnosed within 3 years before early-stage NSCLC diagnosis
- Mental or psychiatric disorders preventing valid informed consent
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Varies according to treatment type
Participants receive either stereotactic body radiotherapy (SBRT) over 3 to 5 fractions or undergo pulmonary anatomical surgery with lymph node dissection.
3 to 5 treatment sessions for SBRT or 1 surgical procedure with hospital stay
Monitoring
Duration - Up to 24 months
Participants are observed with routine clinical data collection including imaging and molecular analyses to assess disease progression and treatment response.
Visits for imaging and sample collection as per clinical follow-up schedule
Trial Site Locations
Total: 2 locations
1
Istituto Europeo di Oncologia IRCCS
Milan, Italy, Italy, 20141
Actively Recruiting
2
Istituto Europeo di Oncologia (IEO) IRCCS
Milan, Lombardy, Italy, 20141
Actively Recruiting
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Research Team
S
Stefania Volpe, MD, PhD
C
Cristiana Fodor, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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