NCT05974475Recruiting
MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 23 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 270 (estimated)
- First submitted
- 26 Jul 2023
- Start date
- 11 Sept 2023
- Primary completion date
- Sept 2026
- Lead sponsor
- European Institute of Oncology
- Diseases
- Lung cancer
- NCT number
- NCT05974475
What you commit to
- Study type: Observational
- Planned participants: 270
- From 11 Sept 2023 to the primary completion date, Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of invasive cancer (within 3 years before the diagnosis of ES-NSCLC);
Other illness
- Mental diseases or psychiatric disorders preventing the acquisition of a valid informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Europeo di Oncologia IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Europeo di Oncologia (IEO) IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.