NCT02491593

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

2.9 years

First QC Date

June 30, 2015

Last Update Submit

November 5, 2018

Conditions

Colorectal Neoplasms

Keywords

fecal occult blood

Outcome Measures

Primary Outcomes (1)

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

    Accuracy of diagnosis in colorectal cancer

    Up to 36 months

Secondary Outcomes (1)

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

    Up to 36 months

Interventions

fecal occult blood testDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Symptoms associated with colorectal cancer (anemia, change of bowel habits, diarrhoea, constipation, haematochezia, weight loss, anorexia)

You may not qualify if:

  • Screening investigations
  • High-risk patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Endoscopy

Eskilstuna, 631 88, Sweden

Location

Related Publications (1)

  • Tsapournas G, Hellstrom PM, Cao Y, Olsson LI. Diagnostic accuracy of a quantitative faecal immunochemical test vs. symptoms suspected for colorectal cancer in patients referred for colonoscopy. Scand J Gastroenterol. 2020 Feb;55(2):184-192. doi: 10.1080/00365521.2019.1708965. Epub 2020 Jan 6.

    PMID: 31906738DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Occult Blood

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Louise Olsson, MD, PhD

    Centre for Clinical research, Eskilstuna, Uppsala universitet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 8, 2015

Study Start

April 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

SE(1)