Understanding the diagnosis and treatment of early and locally advanced non-small cell lung cancer
A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced
This study looks at how patients with early and locally advanced non-small cell lung cancer are diagnosed and treated after surgery or radiation to see how well different approaches work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MSD Italia S.r.l. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 25 sites (San Giovanni Rotondo, FG and 24 other locations) |
| Trial ID | NCT06467383 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world evidence regarding the diagnostic and therapeutic pathways for patients with non-small cell lung cancer (NSCLC) in early and locally advanced stages. It focuses on patients who have undergone curative surgery or radiotherapy between January 2018 and June 2019, analyzing their treatment outcomes and follow-up data until January 2021. The study addresses the variability in treatment approaches across different regions and medical centers, highlighting the need for a standardized strategy in managing NSCLC.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older with stage I-III NSCLC who have received curative treatment.
Not a fit: Patients without available medical records or those enrolled in studies with specific management strategies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols and better patient outcomes for those diagnosed with NSCLC.
How similar studies have performed: Other observational studies have shown success in improving treatment understanding for similar conditions, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with stage I-III NSCLC who have received curative surgery or radiotherapy between January 2018 and June 2019 with available follow-up through January 2021 2. Adult patients (aged ≥ 18 years) at the moment of diagnosis 3. Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent form; privacy Form (ICF). In case of deceased or untraceable patient the investigator before collecting data shall demonstrate and report all necessary measures adopted to contact the patient. Exclusion Criteria: 1. Patients without availability of medical charts or information required 2. Enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.
Where this trial is running
San Giovanni Rotondo, FG and 24 other locations
- IRCCS Casa di sollievo dalla sofferenza — San Giovanni Rotondo, Fg, Italy (Not_yet_recruiting)
- ASST degli Spedali Civili di Brescia — Brescia, Italy (Not_yet_recruiting)
- Gemelli Molise — Campobasso, Italy (Not_yet_recruiting)
- Humanitas Istituto Clinico Catanese — Catania, Italy (Not_yet_recruiting)
- Policlinico Rodolico — Catania, Italy (Not_yet_recruiting)
- AOU Careggi — Florence, Italy (Recruiting)
- IRCCS Policlinico S. Martino — Genova, Italy (Recruiting)
- AO Papardo — Messina, Italy (Not_yet_recruiting)
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
- Istituto Clinico Humanitas — Milan, Italy (Recruiting)
- Istituto Nazionale dei Tumori - Fondazione IRCCS — Milan, Italy (Not_yet_recruiting)
- AOU dei Colli - Monaldi — Naples, Italy (Not_yet_recruiting)
- AOU Vanvitelli — Naples, Italy (Recruiting)
- A.O.U. Maggiore della Carità di Novara — Novara, Italy (Recruiting)
- IOV - Istituto Oncologico veneto - IRCCS — Padova, Italy (Not_yet_recruiting)
- AOUP Policlinico Giaccone — Palermo, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Perugia - Ospedale S. Maria della MIsericordia — Perugia, Italy (Not_yet_recruiting)
- Azienda USL Toscana Centro - Ospedale san Jacopo — Pistoia, Italy (Recruiting)
- Centro di Riferimento Oncologico IRCCS — Pordenone, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Regionale San Carlo di Potenza — Potenza, Italy (Not_yet_recruiting)
- AUSL Romagna Ospedale Santa Maria delle Croci Ravenna — Ravenna, Italy (Not_yet_recruiting)
- IRCCS AUSL Reggio Emilia — Reggio Emilia, Italy (Not_yet_recruiting)
- Fondazione Policlinico Universitario "A. Gemelli" — Roma, Italy (Not_yet_recruiting)
- ASST dei Sette Laghi — Varese, Italy (Not_yet_recruiting)
- AOUI Verona — Verona, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Daniele Righi, PM
- Email: d.righi@yghea.it
- Phone: +39 051 5878211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.