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Clinical Trials/NCT02491593
NCT02491593
Completed
Not Applicable

Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients

Uppsala University1 site in 1 country242 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Uppsala University
Enrollment
242
Locations
1
Primary Endpoint
Number of patients with high fecal blood output in relation to colorectal cancer
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
March 1, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Up to 36 months

Accuracy of diagnosis in colorectal cancer

Secondary Outcomes

  • Number of patients with low fecal blood output in relation to colorectal polyps(Up to 36 months)

Study Sites (1)

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