Rarecells Molecular Biomarkers for Early Detection of Lun... | NCT06546007

Studies
Rarecells Molecular Biomarkers for Early Detection of Lung Cancer

NCT06546007

Sponsor

Rarecells Diagnostics SAS

Status

Recruiting

Last Update Posted

Jun 11, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Lung Cancer
Pulmonary Neoplasm

Interventions

CTC-DNA

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 13, 2024Actual

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Aug 6, 2024

First Submission Date that Met QC Criteria

Aug 6, 2024

First Posted Date

Aug 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2025

Last Update Posted Date

Jun 11, 2025Actual

Name	Class
Meditrial Europe Ltd.	INDUSTRY
Meditrial SrL	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with early lung cancer		Patients with a diagnosis of lung cancer, planned for lung resection with curative intent.	Diagnostic Test: CTC-DNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTC-DNA	Diagnostic Test	ctDNA for the analysis of lung cancer mutations in patients with operable tumors.	Patient with early lung cancer

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Monica Tocchi, MD, PhD	Contact	6469331025		m.tocchi@meditrial.net

Overall Officials

Name	Affiliation	Role
Patrizia Paterlini, MD, PhD	Rarecells	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Università Cattolica del Sacro Cuore Gemelli Hospital	Recruiting	Roma			Italy

Label	URL
Rarecells - sponsor website	View source
Meditrial Contract Research Organization Website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided