Rarecells Molecular Biomarkers for Early Detection of Lung Cancer

Not yet recruiting

• Conditions: Lung Cancer; Pulmonary Neoplasm
• Interventions: Diagnostic Test: CTC-DNA

• Registration Number: NCT06546007
• Lead Sponsor: Rarecells Diagnostics SAS

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2024-11-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with early lung cancer	CTC-DNA	Patients with a diagnosis of lung cancer, planned for lung resection with curative intent.

Primary Outcome Measures

Name	Time	Method
Comparative and complementary in operable patients diagnosed with cancer	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 Outcome Measures

Name	Time	Method
Comparative and complementary sensitivity of CTC-DNA and ctDNA per histological subtype	30 days post procedure	Number of patients with lung cancer-related mutations by CTCDNA alone, by ctDNA alone and by the ctDNA -CTCDNA pair per histologic subtype

Trial Locations

Locations (1)

Università Cattolica del Sacro Cuore Gemelli Hospital; 🇮🇹 Roma, Italy