To hear about similar clinical trials, please enter your email below
Trial Title:
Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
NCT ID:
NCT06546007
Condition:
Lung Cancer
Pulmonary Neoplasm
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Circulating tumor cells
Lung cancer
Circulating tumor DNA
Pulmonary neoplasm
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CTC-DNA
Description:
ctDNA for the analysis of lung cancer mutations in patients with operable tumors.
Arm group label:
Patient with early lung cancer
Other name:
ctDNA
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.
Criteria for eligibility:
Study pop:
Patients with a diagnosis of lung cancer, planned for lung resection with curative
intent.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
35 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Università Cattolica del Sacro Cuore Gemelli Hospital
Address:
City:
Roma
Country:
Italy
Contact:
Last name:
Filippo Lococo, MD
Investigator:
Last name:
Filippo Lococo, MD
Email:
Principal Investigator
Start date:
November 1, 2024
Completion date:
October 1, 2025
Lead sponsor:
Agency:
Rarecells Diagnostics SAS
Agency class:
Industry
Collaborator:
Agency:
Meditrial Europe Ltd.
Agency class:
Industry
Collaborator:
Agency:
Meditrial SrL
Agency class:
Industry
Source:
Rarecells Diagnostics SAS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06546007
http://www.rarecells.com
http://www.meditrial.net
