NCT06788366Recruiting
AI-HOPE Lung Cancer: Building a Predictive Tool for Metastatic Lung Cancer
Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of our project is building a predictive response algorithm for patients with metastatic lung cancer, exploiting an artificial intelligence platform. It will collect patient information from all areas (clinical, laboratory, radiological, pathological) and analyse them, understanding connections and correlations, both at baseline and at pre-specified timepoints. It would lead to the development of a reliable and constantly evolving predictive score, able to continuously re-weight the importance of each variable as new data come in. Since the greatest clinical need is identifying non-responders to immunotherapy and chemo-immunotherapy combination (30% of all treated patients), these two populations are defined as the starting cohorts (Cohort A, immunotherapy alone, Cohort B, chemo-immunotherapy combinations). For each cohort, three main questions are to be answered: Q1) Early progressors (defined as progressive disease or death within three months of treatment or at first radiological restaging) Q2) Toxicity (with a special focus on severe toxicities G≥3) Q3) Long survivors (defined as patients reaching an overall survival of at least 1.5x median overall survival in registrative trials) The early identification of non-responders, high-risk patients (or on the other hand, long survivors) would help their healthcare planning, providing individualised follow-up strategies or prompting their inclusion in alternative treatments (eg clinical trials). For all cohorts, first data entry will be retrospective and second data entry will be prospective (as validation set).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 29 Feb 2024
- Start date
- 12 Feb 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Lung cancer
- NCT number
- NCT06788366
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 12 Feb 2024 to the primary completion date, 31 Dec 2026
- 1 site 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.
Other
- Patients with other thoracic tumours non-NSCLC (i.e. SCLC)
- Stage other than IV or feasible for radical treatment upfront
- Treatment within clinical trials (with combination regimens different from the aforementioned combinations)
- Lost to follow-up
Who the study is looking for
- Patients with histological or cytological diagnosis of NSCLC
- Stage IV according to investigator's staging procedures (or any locally advanced tumour not feasible for local radical treatment)
- Treatment with at least 1 cycle of mono-immunotherapy or chemo-immunotherapy (as per clinical practice)
- Availability of follow-up
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Francesca Rita Ogliari Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.