Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515821
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Multicentre Study for Data Collection Development and Evaluation of Novel CRC Screening and Diagnostic Methods
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicentre Observational Study for the Data Collection Development and Evaluation of the Performance of Novel CRC Screening and Diagnostic Methods ONCOSCREEN-CS
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The primary goal is to develop easy accessible diagnostic tools for high risk subjects for colon cancer in different European populations to improve early CRC detection These CRC screening technologies would be low cost breakthrough and of high sensitivity and specificity
Detailed Description:
Colorectal Cancer CRC is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women CRC can often be prevented through regular screening Although colonoscopy-based screening programs result in a significant decrease in CRC incidence the compliance rate for performing the required screening remains too low and not the desired one Fecal Occult Blood Test FOBT is another widely used screening modality for CRC but have certain constraints such as relatively low sensitivity and the need for multiple sampling three to reach full screening potential The development of novel more practical screening methods can effectively increase the screening rates for CRC through non-invasive repeatable cost-effective easy-to-use and patient-friendly procedures This is of particular importance in different European societies and population subgroups since an increase in the incidence of Early-Onset CRC is currently noticed which is significantly associated with risk factors such as heredity obesity smoking alcohol abuse and hyperlipidemia
Within this framework ONCOSCREEN will develop a multi-tier diagnostic solution towards improved CRC screening Furthermore ONCOSCREEN will consider specific socio-economic determinants which increase the regional or national CRC risks thus exploiting new solutions particularly in younger high-risk individuals in European communities For the validation of the developed solution a clinical validation study titled ONCOSCREEN-CS will be conducted to assess its effectiveness sensitivity and specificity in detecting CRC at an early stage During the first phase of the study ONCOSCREEN-CS-Phase A the investigators will identify the different expression patterns of the four diagnostic solutions ONCO-VOC ONCO-CRISP ONCO-NMR ONCO-CTC in CRC patients and healthy controls with high risk for CRC and also initially estimate their sensitivity and specificity During the second phase ONCOSCREEN-CS-Phase B the ONCOSCREEN solution will be clinically validated
Within this framework ONCOSCREEN will develop a multi-tier diagnostic solution towards improved CRC screening Furthermore ONCOSCREEN will consider specific socio-economic determinants which increase the regional or national CRC risks thus exploiting new solutions particularly in younger high-risk individuals in European communities For the validation of the developed solution a clinical validation study titled ONCOSCREEN-CS will be conducted to assess its effectiveness sensitivity and specificity in detecting CRC at an early stage During the first phase of the study ONCOSCREEN-CS-Phase A the investigators will identify the different expression patterns of the four diagnostic solutions ONCO-VOC ONCO-CRISP ONCO-NMR ONCO-CTC in CRC patients and healthy controls with high risk for CRC and also initially estimate their sensitivity and specificity During the second phase ONCOSCREEN-CS-Phase B the ONCOSCREEN solution will be clinically validated
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