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Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients

Completed
Conditions
Colorectal Neoplasms
Registration Number
NCT02491593
Lead Sponsor
Uppsala University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
242
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of patients with high fecal blood output in relation to colorectal cancerUp to 36 months

Accuracy of diagnosis in colorectal cancer

Secondary Outcome Measures
NameTimeMethod
Number of patients with low fecal blood output in relation to colorectal polypsUp to 36 months

Accuracy of diagnosis of colorectal polyps

Trial Locations

Locations (1)

Unit of Endoscopy

πŸ‡ΈπŸ‡ͺ

Eskilstuna, Sweden

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