Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients

Uppsala University242 enrolled

Overview

The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.

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.

Study Type

OBSERVATIONAL

Enrollment

242

Conditions

Colorectal Neoplasms

Interventions

fecal occult blood testDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unit of Endoscopy

Eskilstuna, Sweden

Outcomes

Primary Outcomes

Number of patients with high fecal blood output in relation to colorectal cancer

Accuracy of diagnosis in colorectal cancer

Time frame: Up to 36 months

Secondary Outcomes

Number of patients with low fecal blood output in relation to colorectal polyps

Accuracy of diagnosis of colorectal polyps

Time frame: Up to 36 months

Data from ClinicalTrials.gov

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