Cancer statistics, 2020.
Rebecca L Siegel, Kimberly D Miller, Ahmedin Jemal
https://pubmed.ncbi.nlm.nih.gov/31912902Actively Recruiting
Age: 18Years +
All Genders
ID06467383
A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced
Led by MSD Italia S.r.l. · Updated on 2025-01-14
600
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
Sponsors
M
MSD Italia S.r.l.
Lead Sponsor
Y
YGHEA, CRO Division of Ecol Studio spa
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a non-interventional, retrospective observational study to better understand the diagnosis and treatment of patients with early-stage and locally advanced non-small cell lung cancer (NSCLC), specifically stages I to III. The study addresses the variability in treatment approaches, as there is no clear consensus on the best timing, sequence, or combination of surgery, chemotherapy, and radiotherapy for these patients. This research aims to collect real-world data to improve knowledge on how these patients are managed across different healthcare settings. This study involves reviewing past medical records of patients diagnosed with stage I-III NSCLC who underwent curative surgery or radiotherapy between January 2018 and June 2019. The data collection covers treatment approaches, discussions in multidisciplinary teams, healthcare resource use, and direct medical costs from January 2018 to January 2021. There are no interventions or treatments being given directly as part of this study since it is observational and retrospective. Participants' involvement consists of allowing access to their medical charts and treatment records for data capture. Researchers will evaluate treatment timelines and approaches as they occurred in routine clinical practice. The study also tracks the extent of healthcare resources used and costs involved. Data privacy is maintained by obtaining informed consent from patients or their representatives. The study is expected to conclude in June 2025.
CONDITIONS
Brief Title
A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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
- Adult patients (aged 6 18 years) at the moment of diagnosis
- Patients or their legally acceptable representatives must have signed and dated the Informed Consent form and privacy form
You will not qualify if you...
- Patients without availability of medical charts or required information
- Patients enrolled in studies requiring specific management that differs from the site's normal clinical practice
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Retrospective from January 2018 to January 2021
Participants undergo diagnostic assessments to characterize their NSCLC stage and plan treatment.
Data collected from medical charts during usual care
Long-term Monitoring
Duration - Retrospective from January 2018 to January 2021
Participants with stage I-III NSCLC are observed through their treatment path including surgery, chemotherapy, and radiotherapy as per routine clinical practice.
Follow-up visits and treatments as per standard care
Trial Site Locations
Total: 25 locations
1
IRCCS Casa di sollievo dalla sofferenza
San Giovanni Rotondo, FG, Italy
Not Yet Recruiting
2
ASST degli Spedali Civili di Brescia
Brescia, Italy
Not Yet Recruiting
3
Gemelli Molise
Campobasso, Italy
Not Yet Recruiting
4
Humanitas Istituto Clinico Catanese
Catania, Italy
Not Yet Recruiting
5
Policlinico Rodolico
Catania, Italy
Not Yet Recruiting
6
AOU Careggi
Florence, Italy
Actively Recruiting
7
IRCCS Policlinico S. Martino
Genova, Italy
Actively Recruiting
8
AO Papardo
Messina, Italy
Not Yet Recruiting
9
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
10
Istituto Clinico Humanitas
Milan, Italy
Actively Recruiting
11
Istituto Nazionale dei Tumori - Fondazione IRCCS
Milan, Italy
Not Yet Recruiting
12
AOU dei Colli - Monaldi
Naples, Italy
Not Yet Recruiting
13
AOU Vanvitelli
Naples, Italy
Actively Recruiting
14
A.O.U. Maggiore della Carità di Novara
Novara, Italy
Actively Recruiting
15
IOV - Istituto Oncologico veneto - IRCCS
Padova, Italy
Not Yet Recruiting
16
AOUP Policlinico Giaccone
Palermo, Italy
Not Yet Recruiting
17
Azienda Ospedaliera Perugia - Ospedale S. Maria della MIsericordia
Perugia, Italy
Not Yet Recruiting
18
Azienda USL Toscana Centro - Ospedale san Jacopo
Pistoia, Italy
Actively Recruiting
19
Centro di Riferimento Oncologico IRCCS
Pordenone, Italy
Not Yet Recruiting
20
Azienda Ospedaliera Regionale San Carlo di Potenza
Potenza, Italy
Not Yet Recruiting
21
AUSL Romagna Ospedale Santa Maria delle Croci Ravenna
Ravenna, Italy
Not Yet Recruiting
22
IRCCS AUSL Reggio Emilia
Reggio Emilia, Italy
Not Yet Recruiting
23
Fondazione Policlinico Universitario "A. Gemelli"
Roma, Italy
Not Yet Recruiting
24
ASST dei Sette Laghi
Varese, Italy
Not Yet Recruiting
25
AOUI Verona
Verona, Italy
Not Yet Recruiting
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Research Team
D
Daniele Righi, PM
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Joshua E Rosen, Hari B Keshava, Xiaopan Yao...
https://pubmed.ncbi.nlm.nih.gov/27041452Disparities in survival following surgery among patients with different histological types of N2-III non-small cell lung cancer: a Surveillance, Epidemiology and End Results (SEER) database analysis.
Gang Jin, Xin Wang, Cai Xu...
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David Ball, G Tao Mai, Shalini Vinod...
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Suresh Senan, Anthony Brade, Lu-Hua Wang...
https://pubmed.ncbi.nlm.nih.gov/26811519Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study.
Jeffrey D Bradley, Rebecca Paulus, Ritsuko Komaki...
https://pubmed.ncbi.nlm.nih.gov/25601342Deriving stage at diagnosis from multiple population-based sources: colorectal and lung cancer in England.
S Benitez-Majano, H Fowler, C Maringe...
https://pubmed.ncbi.nlm.nih.gov/27328310Definitive chemoradiation for the treatment of locally advanced non small-cell lung cancer.
A William Blackstock, Ramaswamy Govindan
https://pubmed.ncbi.nlm.nih.gov/17827465