Clinical Study To Evaluate the Sensitivity of Circulating Iset® by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Rarecells Diagnostics SAS
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Comparative and complementary in operable patients diagnosed with cancer
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
Early diagnosis of these cancers 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Comparative and complementary in operable patients diagnosed with cancer
Time Frame: 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
Secondary Outcomes
- Comparative and complementary sensitivity of CTC-DNA and ctDNA per histological subtype(30 days post procedure)