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Clinical Trials in Italy / NCT06546007
Recruiting Observational

Rarecells Molecular Biomarkers for Early Detection of Lung Cancer

NCT06546007 · tracked via the Priya Life Science Italy tracker
Sponsor
Rarecells Diagnostics SAS
Phase
Observational
Started
2024-11-13
Last updated
2025-06-11

Condition(s) studied

Lung CancerPulmonary Neoplasm

Investigational drug(s) / intervention(s)

CTC-DNA

CTC-DNA: ctDNA for the analysis of lung cancer mutations in patients with operable tumors.

Study summary

Early diagnosis of lung cancer is a public health priority. Additionally, early detection of recurrences after treatment is crucial for optimizing disease management.

This study seeks to demonstrate the accuracy of the Rarecells ISET® circulating tumor cells DNA (CTC-DNA), combined with circulating tumor DNA (ctDNA), for the early diagnosis of lung cancer.

Eligibility

Sex
ALL
Min age
35 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female aged between 35 and 85 years 2. Patient diagnosed with resectable lung cancer (by imaging and/or pathological examination) not yet treated for this cancer. 3. Patient capable of giving free, informed, and express consent The assessment of successful elected surgery implies, but is not limited to, the following: * Exclusion of detectable extra thoracic and distant metastases * Determination of the presence or absence of superior mediastinal lymph node metastases * Definition of the histologic or cell type, whenever possible * Evaluation of operative risk Exclusion Criteria: 1. Patient diagnosed and/or treated previously for lung cancer or another cancer, regardless of duration 2. Patient treated with neoadjuvant treatment 3. Pregnant women 4. Patient presenting psychiatric or neurological disorders preventing them from understanding the research

Primary outcome measure(s)

  • Comparative and complementary in operable patients diagnosed with cancer — 30 days post procedure
    Number of patients with lung cancer-related mutations by CTCDNA alone, by ctDNA alone and by the ctDNA -CTCDNA pair divided by the number of patients with cancer enrolled in the study

Trial sites (1)

FacilityCityRegionStatus
Università Cattolica del Sacro Cuore Gemelli Hospital Roma Italy Recruiting

Other trials for the same condition

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Vapor Ablation for Localized Cancer Lesions Starting soon
Ambispective Registry of Patients Affected by Lung Cancer Recruiting
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors Recruiting
Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06546007 on ClinicalTrials.gov ↗ ← All trials in Italy