Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients

Colorectal Neoplasms Clinical Trial

— FIKA  

Official title:

Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491593
• Other study ID #: QFecalBlood 2013/2:7
• Status: Completed
• Start date: April 2014
• Est. completion date: March 1, 2017

Study information

• Verified date: November 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• fecal occult blood test

Locations

Country	Name	City	State
Sweden	Unit of Endoscopy	Eskilstuna

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with high fecal blood output in relation to colorectal cancer	Accuracy of diagnosis in colorectal cancer	Up to 36 months
Secondary	Number of patients with low fecal blood output in relation to colorectal polyps	Accuracy of diagnosis of colorectal polyps	Up to 36 months