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Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients

Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02491593
Acronym
FIKA
Enrollment
242
Registered
2015-07-08
Start date
2014-04-30
Completion date
2017-03-01
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

fecal occult blood

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.

Interventions

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Symptoms associated with colorectal cancer (anemia, change of bowel habits, diarrhoea, constipation, haematochezia, weight loss, anorexia)

Exclusion criteria

* Screening investigations * High-risk patients

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with high fecal blood output in relation to colorectal cancerUp to 36 monthsAccuracy of diagnosis in colorectal cancer

Secondary

MeasureTime frameDescription
Number of patients with low fecal blood output in relation to colorectal polypsUp to 36 monthsAccuracy of diagnosis of colorectal polyps

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026