Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 7:51 PM
Study NCT ID:
NCT02491593
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2015-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients
Sponsor:
Uppsala University
Organization:
Study Overview
Official Title:
Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
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:
FIKA
Brief Summary:
The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.
Detailed Description:
Consecutive patients referred from primary care for colonoscopy due to symptoms are eligible. Patients will receive written information of the study together with the time for colonoscopy. A specific research nurse will call them and for those accepting participation, history and current medication will be collected. Kits will be sent to patients and they will provide three faecal samples before examination. These will be analysed at one certified laboratory.
Hemoglobin concentration will be notified in the range of 50 - \< 1000 ng/mL, or as a negative outcome.
Macroscopic findings at the colonoscopy will be collected, as well as the outcome of the pathological report.
Hemoglobin concentration will be notified in the range of 50 - \< 1000 ng/mL, or as a negative outcome.
Macroscopic findings at the colonoscopy will be collected, as well as the outcome of the pathological report.
Study Oversight
Has Oversight DMC:
False
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?: