NCT05706883Completed
Clinical and Molecular Findings in Patients With Cervical/Supraclavicular Metastasis From Non-small-cell Lung Cancer (NSCLC)
Mutational Profile of Patients With and Without Neck and Supraclavicular Lymph Nodes Metastasis From Advanced Non-squamous Non-small-cell Lung Cancer: a Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 5 Apr 2024
Brief summary (registry, in English)
Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Enlarged and/or positron emission tomography (PET) positive cervical/supraclavicular lymph nodes (CSLs) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (US-NAB). However, the prevalence of metastatic involvement of CSLs in patients with advanced lung cancer was never specifically assessed. Furthermore, the possible association of malignant CSLs involvement with molecular status was never investigated, unlike what was done for several other metastatic sites.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 348 (actual)
- First submitted
- 9 Jan 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 30 Sept 2023
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Lung cancer
- NCT number
- NCT05706883
What you commit to
- Study type: Observational
- Participants enrolled: 348
- From 1 Jan 2023 to the primary completion date, 30 Sept 2023
- 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.
Prior treatment
- Inability to stop anticoagulant or antiplatelet therapy before the procedure (except acetylsalicylic acid 100 mg/day);
Lab values
- Platelet count \<50.000 per μL;
Other
- Patients with known non-squamous NSCLC sent for re-biopsy after first or second line treatment;
- Inability or unwillingness to provide a written informed consent.
Who the study is looking for
- Age \>18 years at the time of the procedure;
- Suspected advanced, treatment naïve non-squamous NSCLC ;
- Indication to biopsy for diagnosis and/or molecular profiling;
- Written informed consent to the study participation.
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 |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.