Viewing Study NCT06546007



Ignite Creation Date: 2024-10-25 @ 8:00 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06546007
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-06

Brief Title: Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
Sponsor: None
Organization: None

Study Overview

Official Title: Clinical Study To Evaluate the Sensitivity of Circulating Iset by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BioMolCTC
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None