Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients (FIKA)

November 5, 2018 updated by: Uppsala University
The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Eskilstuna, Sweden, 631 88
        • Unit of Endoscopy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred from primary care for investigation of symptoms potentially caused by colorectal cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Louise Olsson, MD, PhD, Centre for Clinical research, Eskilstuna, Uppsala universitet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QFecalBlood 2013/2:7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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