Viewing Study NCT06607614



Ignite Creation Date: 2024-10-26 @ 3:40 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06607614
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-19

Brief Title: A Predictive Model Based on Quantitative Fecal Immunochemical Test Can Stratify the Risk of CRC in an Organized Screening Program
Sponsor: None
Organization: None

Study Overview

Official Title: Prioritizing Resumption of Colorectal Screening After COVID
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: PRIORITIZE
Brief Summary: The COVID-19 pandemic has disrupted every aspect of medical care including screening programs and preventive medical care Organized FIT-based colorectal cancer screening programs make no exception since their efficacy depends on a multi-tiered series of interventions that were hampered by the pandemic at multiple levels In detail the first level of intervention namely population based FIT tests distributed to the population has seen a dramatic decrease of number of tests performed for both organizational reasons ie less personnel deployed to testing sites and for failure to present fecal samples from patients for fear of contagion or impossibility to reach the drop-off sites for state-imposed limitations Secondly the referral of FIT positive patients to subsequent colonoscopy was stopped or delayed since endoscopy services have been undergoing only emergent and urgent procedures Thirdly patients diagnosed with advanced neoplasia or cancer have seen their endoscopic or surgical removal procedures delayed or canceled Regarding post-FIT colonoscopy workup European Screening Guidelines recommend a 30-day maximum span between a positive FIT test and subsequent colonoscopy It is well known that any delay in post-FIT colonoscopy results in an increase in advanced neoplasia and colorectal cancer that reaches dramatic levels after 6 months

Our purpose is to develop and validate using the quantitative level of faecal hemoglobin found in FIT a simple scoring system to effectively sub-stratify CRC risk of FIT positive patients
Detailed Description: None

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