Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831632
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-04-01
Brief Title:
Diagnostic Performance Assessment of Qualitative Ifobt and Quantitative Ifobt for Advanced Neoplastic
Sponsor:
CECILIA CURVALE
Organization:
Hospital El Cruce
Study Overview
Official Title:
Diagnostic Performance Assessment of Qualitative Ifobt and Various Quantitative Ifobt Cut-off Points for Advanced Neoplastic Wound Screening in an Argentine Patient Cohort
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Argentina there is vast experience in qualitative iFOBT population screening that is part of the CRC Prevention and Early Detection National Program The screenings cut-off point is at 50 ngmL buffer Its positivity rate for 2019 has been an average of 2615 over the double of the one reported in the international literature 75-11 for this cut-off point 1 There are no studies that assess such technology and suggest an appropriate cut-off point for this population The goal of this study is to assess the diagnostic performance of the qualitative iFOBT used in the present and the quantitative iFOBT with various cut-off points for advanced neoplastic wound screening colorectal cancer and advanced adenoma in an Argentine patient cohort
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None