- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706883
Clinical and Molecular Findings in Patients With Cervical/Supraclavicular Metastasis From Non-small-cell Lung Cancer (NSCLC) (ProphetaPro)
April 4, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
348
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Valeria Cetoretta, MD
- Phone Number: +393339459818
- Email: valeria.cetoretta@unito.it
Study Contact Backup
- Name: Maria Chiara Flore, MD
- Email: mariachiara.flore@guest.policlinicogemelli.it
Study Locations
-
-
-
Roma, Italy
- Fondazione Policlinico Universitario Agostino Gemelli Irccs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with clinical and radiological suspicion of advanced lung cancer
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with known non-squamous NSCLC sent for re-biopsy after first or second line treatment;
- Inability to stop anticoagulant or antiplatelet therapy before the procedure (except acetylsalicylic acid 100 mg/day);
- Platelet count <50.000 per μL;
- Inability or unwillingness to provide a written informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Experimental group
Patients with advanced lung cancer featuring cervical and/or supraclavicular lymph node metastasis
|
Patients with evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes suspected of being metastasis from lung cancer will be submitted to the biopsy from this location.
Other Names:
|
Control group
Patients with advanced lung cancer NOT featuring cervical and/or supraclavicular lymph node metastasis
|
Patients without evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes will be submitted to the biopsy considered less invasive and effective based on imaging data and clinical health status.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of KRAS mutation
Time Frame: 2 months
|
Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of EGFR, ALK, ROS1, BRAF, RET, MET, NTRK
Time Frame: 2 months
|
Number of participants with EGFR, ALK, ROS1, BRAF, RET, MET, NTRK mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)
|
2 months
|
Tumor proportion score of PD-L1
Time Frame: 2 months
|
Number of participants with a tumor proportion score of PD-L1 < 1%; 1-50%; >50% in the two groups (patients with and without cervical/supraclavicular lymph node metastasis)
|
2 months
|
Prevalence of cervical/supraclavicular lymph node metastasis
Time Frame: 2 months
|
Number of participants with cervical/supraclavicular lymph node metastasis in the whole cohort of patients with stage IV lung cancer
|
2 months
|
Predictors of cervical/supraclavicular lymph node metastasis
Time Frame: 6 months
|
Association between the presence of cervical/supraclavicular lymph node metastasis and the following factors: age, sex, smoking habit, tumor histologic type, central vs peripheral primary tumor, enlarged and/or PET positive N2 or N3 lymph nodes in the middle mediastinum, and molecular profile.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rocco Trisolini, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
September 30, 2023
Study Completion (Actual)
November 30, 2023
Study Registration Dates
First Submitted
January 9, 2023
First Submitted That Met QC Criteria
January 23, 2023
First Posted (Actual)
January 31, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 4, 2024
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5394
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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