RecruitingNCT06546007

Rarecells Molecular Biomarkers for Early Detection of Lung Cancer

Clinical Study To Evaluate the Sensitivity of Circulating Iset® by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer


Sponsor

Rarecells Diagnostics SAS

Enrollment

50 participants

Start Date

Nov 13, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 35 YearsMax Age: 85 Years

Inclusion Criteria8

  • Male or female aged between 35 and 85 years
  • Patient diagnosed with resectable lung cancer (by imaging and/or pathological examination) not yet treated for this cancer.
  • 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 Criteria4

  • Patient diagnosed and/or treated previously for lung cancer or another cancer, regardless of duration
  • Patient treated with neoadjuvant treatment
  • Pregnant women
  • Patient presenting psychiatric or neurological disorders preventing them from understanding the research

Interventions

DIAGNOSTIC_TESTCTC-DNA

ctDNA for the analysis of lung cancer mutations in patients with operable tumors.


Locations(1)

Università Cattolica del Sacro Cuore Gemelli Hospital

Roma, Italy

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NCT06546007


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