Lung CancerBioMolCTCNCT06546007
Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
An observational study of Lung Cancer and Pulmonary Neoplasm, run by Rarecells Diagnostics SAS at 1 site in Italy.
Trial 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)… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Lung Cancer, Pulmonary Neoplasm
- What is being tested?
- CTC-DNA
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 13 Nov 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of lung cancer, planned for lung resection with curative intent.
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università Cattolica del Sacro Cuore Gemelli Hospital
Roma
Filippo Lococo, MD
Filippo Lococo, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Pulmonary Neoplasm
- Being tested
- CTC-DNA
- Keywords
- Circulating tumor cells, Lung cancer, Circulating tumor DNA, Pulmonary neoplasm
- Medical subject headings
- Lung Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC-DNADiagnostic test
Also called ctDNA
ctDNA for the analysis of lung cancer mutations in patients with operable tumors.
| Study group | Role | What they receive |
|---|---|---|
| Patient with early lung cancer | Patients with a diagnosis of lung cancer, planned for lung resection with curative intent. Receives: Diagnostic Test: CTC-DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post procedure
Secondary outcomes (1)
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
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start13 Nov 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rarecells Diagnostics SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd., Meditrial SrL
- Responsible party
- Sponsor
- Investigators
- Patrizia Paterlini, MD, PhD, Study director, Rarecells
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546007
- Sponsor's protocol ID
- BIOMOLCTC-24-01
- Acronym
- BioMolCTC
- Status last verified
- Jun 2025
- First submitted
- 6 Aug 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study To Evaluate the Sensitivity of Circulating Iset® by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
- ClinicalTrials.gov ID
- NCT06546007
- Acronym / sponsor ID
- BioMolCTC / BIOMOLCTC-24-01
- Conditions
- Lung Cancer, Pulmonary Neoplasm
- Keywords
- Circulating tumor cells, Lung cancer, Circulating tumor DNA, Pulmonary neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rarecells Diagnostics SASIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd., Meditrial SrL
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with early lung cancer | – | Diagnostic Test: CTC-DNAPatients with a diagnosis of lung cancer, planned for lung resection with curative intent. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of lung cancer, planned for lung resection with curative intent.
Key inclusion criteria (8 listed)
- 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:
- Exclusion of detectable extra thoracic and distant metastases
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTC-DNAAlso: ctDNActDNA for the analysis of lung cancer mutations in patients with operable tumors. | Diagnostic test | Patient with early lung cancer |
Primary outcome
Comparative and complementary in operable patients diagnosed with cancer
Time frame: 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
1 secondary outcome
Comparative and complementary sensitivity of CTC-DNA and ctDNA per histological subtype
Time frame: 30 days post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Rarecells - sponsor websiteLink provided by the sponsor.
- Meditrial Contract Research Organization WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrizia Paterlini, MD, PhD study director
Rarecells
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Pulmonary Neoplasm, run by Rarecells Diagnostics SAS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Tocchi, MD, PhD (6469331025, m.tocchi@meditrial.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative and complementary in operable patients diagnosed with cancer (time frame: 30 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.