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Completed

NCT Number: NCT02491593

Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients

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

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unit of Endoscopy

Eskilstuna, 631 88, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fecal occult blood test

Device

Primary outcomes

  1. 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

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

    Time frame: Up to 36 months

    Accuracy of diagnosis of colorectal polyps

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Acronym: FIKA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 8, 2015
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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