Clinical trial NCT06546007: Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
Official title: Clinical Study To Evaluate the Sensitivity of Circulating Iset® by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Pulmonary Neoplasm
Keywords: Circulating tumor cells
Lung cancer
Circulating tumor DNA
Pulmonary neoplasm
Lead sponsor: Rarecells Diagnostics SAS
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
name: Meditrial SrL
First posted: 2024-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of lung cancer, planned for lung resection with curative intent.

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Comparative and complementary in operable patients diagnosed with cancer
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Comparative and complementary sensitivity of CTC-DNA and ctDNA per histological subtype
timeFrame: 30 days post procedure
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore Gemelli Hospital
Study officials:
affiliation: Rarecells
name: Patrizia Paterlini, MD, PhD
role: STUDY_DIRECTOR
References: