Rarecells Molecular Biomarkers for Early Detection of Lung Cancer

Last updated: June 10, 2025
Sponsor: Rarecells Diagnostics SAS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Lung Cancer

Non-small Cell Lung Cancer

Treatment

CTC-DNA

Clinical Study ID

NCT06546007
BIOMOLCTC-24-01
  • Ages 35-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female aged between 35 and 85 years

  2. Patient diagnosed with resectable lung cancer (by imaging and/or pathologicalexamination) 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 nodemetastases

  • Definition of the histologic or cell type, whenever possible

  • Evaluation of operative risk

Exclusion

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 fromunderstanding the research

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: CTC-DNA
Phase:
Study Start date:
November 13, 2024
Estimated Completion Date:
October 01, 2025

Study 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.

Connect with a study center

  • Università Cattolica del Sacro Cuore Gemelli Hospital

    Roma,
    Italy

    Active - Recruiting

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