Rarecells Molecular Biomarkers for Early Detection of Lung Cancer

Rarecells Diagnostics SAS50 enrolled

Overview

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.

Researching for tumor biomarkers in the blood, circulating tumor cells (CTCs), and circulating tumor DNA (ctDNA) can non-invasively detect signs of cancer without risk to the patient. These are ideal and risk-free methods for monitoring patients and early detection of lung cancer. This study aims to assess the sensitivity of molecular analyses performed on circulating tumor DNA in the blood and on DNA from circulating tumor cells, isolated using the highly sensitive ISET® method. The purpose is to assess two circulating molecular biomarkers in the field of liquid biopsy in patients with lung cancer: Rarecells ISET® CTC-DNA and ctDNA. Subjects eligible for inclusion in the study are individuals diagnosed with operable lung cancer who will undergo biopsy or surgical resection of the tumor. Upon enrolment in the trial, participants will undergo an assessment including low-dose CT scan, isolation of CTCs by the ISET® method, and separation of plasma for analysis of ctDNA.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lung Cancer Pulmonary Neoplasm

Interventions

CTC-DNADIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Università Cattolica del Sacro Cuore Gemelli Hospital

Roma, Italy

RECRUITING

Outcomes

Primary Outcomes

Comparative and complementary in operable patients diagnosed with cancer

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

Time frame: 30 days post procedure

Secondary Outcomes

Comparative and complementary sensitivity of CTC-DNA and ctDNA per histological subtype

Number of patients with lung cancer-related mutations by CTCDNA alone, by ctDNA alone and by the ctDNA -CTCDNA pair per histologic subtype

Time frame: 30 days post procedure

Central Contacts

Monica Tocchi, MD, PhD

CONTACT

6469331025 m.tocchi@meditrial.net

Data from ClinicalTrials.gov

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