Rarecells Molecular Biomarkers for Early Detection of Lung Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-85
SponsorRarecells Diagnostics SAS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Exclusion of detectable extra thoracic and distant metastases

Disqualifiers

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

Trial population

Patients with a diagnosis of lung cancer, planned for lung resection with curative intent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CTC-DNA

    Diagnostic test

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patient with early lung cancer1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rarecells Diagnostics SAS

Lead sponsor

Meditrial Europe Ltd.

Collaborator

Meditrial SrL

Collaborator