Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CTC-DNA.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Pulmonary Neoplasm. Basic parameters: 35 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study To Evaluate the Sensitivity of Circulating Iset® by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
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.
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.
Interventions
- Diagnostic test CTC-DNA
ctDNA for the analysis of lung cancer mutations in patients with operable tumors.
Primary outcome measures
- Comparative and complementary in operable patients diagnosed with cancer [Time frame: 30 days post procedure]
Secondary outcome measures (1)
- Comparative and complementary sensitivity of CTC-DNA and ctDNA per histological subtype [Time frame: 30 days post procedure]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Università Cattolica del Sacro Cuore Gemelli Hospital — Roma
Identifiers
NCT: NCT06546007 · BIOMOLCTC-24-01