Rarecells Molecular Biomarkers for Early Detection of Lung Cancer

NCT06546007 | Recruiting

• 1 other identifier: BIOMOLCTC-24-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Pulmonary Neoplasm

Keywords

Circulating tumor cells; Lung cancer; Circulating tumor DNA; Pulmonary neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparative and complementary sensitivity of CTC-DNA and ctDNA per histological subtype

  30 days post procedure

Study Arms (1)

Patient with early lung cancer

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

Diagnostic Test: CTC-DNA

Interventions

CTC-DNA DIAGNOSTIC_TEST

ctDNA for the analysis of lung cancer mutations in patients with operable tumors.

Also known as: ctDNA

Patient with early lung cancer

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rarecells Diagnostics SAS: lead
• Meditrial Europe Ltd.: collaborator
• Meditrial SrL: collaborator

Study Sites (1)

Università Cattolica del Sacro Cuore Gemelli Hospital

Roma, Italy

RECRUITING

Related Links

• Rarecells - sponsor website
• Meditrial Contract Research Organization Website

Biospecimen

Retention: SAMPLES WITH DNA

Analysis of tumor DNA (CTC-DNA) in blood samples from subjects with lung cancer undergoing lung surgery.

MeSH Terms

Conditions

Lung Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrizia Paterlini, MD, PhD

  Rarecells

  STUDY DIRECTOR

Central Study Contacts

Monica Tocchi, MD, PhD

CONTACT

6469331025; m.tocchi@meditrial.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: November 13, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)