Rarecells Molecular Biomarkers for Early Detection of Lung Cancer (BioMolCTC)

Clinical Study To Evaluate the Sensitivity of Circulating Iset® by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Pulmonary Neoplasm
• Intervention / Treatment: Diagnostic test: CTC-DNA

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Monica Tocchi, MD, PhD; Phone Number: 6469331025; Email: m.tocchi@meditrial.net

Study Locations

• Italy
  • Roma, Italy
    • Recruiting
    • Università Cattolica del Sacro Cuore Gemelli Hospital
    • Contact: Filippo Lococo, MD
    • Principal Investigator: Filippo Lococo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with early lung cancer; Patients with a diagnosis of lung cancer, planned for lung resection with curative intent.	Diagnostic test: CTC-DNA; ctDNA for the analysis of lung cancer mutations in patients with operable tumors.; Other Names: ctDNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days post procedure

Collaborators and Investigators

• Sponsor: Rarecells Diagnostics SAS
• Collaborators: Meditrial Europe Ltd.; Meditrial SrL
• Investigators: Study Director: Patrizia Paterlini, MD, PhD, Rarecells

Publications and helpful links

Helpful Links

• Rarecells - sponsor website
• Meditrial Contract Research Organization Website

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Lung cancer; Circulating tumor DNA; Circulating tumor cells; Pulmonary neoplasm
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: BIOMOLCTC-24-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No