Colorectal NeoplasmsFIKANCT02491593
Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients
An observational study of Colorectal Neoplasms, run by Uppsala University at 1 site in Sweden.
Trial summary
The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- fecal occult blood test
- Type of treatment
- Medical device
- How many people
- 242 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to 1 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred from primary care for investigation of symptoms potentially caused by colorectal cancer
Who may be able to join
- Symptoms associated with colorectal cancer (anemia, change of bowel habits, diarrhoea, constipation, haematochezia, weight loss, anorexia)
Who cannot join
- Screening investigations
- High-risk patients
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.
Read the 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- fecal occult blood test
- Keywords
- fecal occult blood
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal occult blood testDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with high fecal blood output in relation to colorectal cancer
Accuracy of diagnosis in colorectal cancer
Measured: Up to 36 months
Secondary outcomes (1)
Number of patients with low fecal blood output in relation to colorectal polyps
Accuracy of diagnosis of colorectal polyps
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startApr 2014
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Olsson, MD, PhD, Principal investigator, Centre for Clinical research, Eskilstuna, Uppsala universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491593
- Sponsor's protocol ID
- QFecalBlood 2013/2:7
- Acronym
- FIKA
- Status last verified
- Nov 2018
- First submitted
- 30 Jun 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31906738
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients
- ClinicalTrials.gov ID
- NCT02491593
- Acronym / sponsor ID
- FIKA / QFecalBlood 2013/2:7
- Conditions
- Colorectal Neoplasms
- Keywords
- fecal occult blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred from primary care for investigation of symptoms potentially caused by colorectal cancer
Key inclusion criteria (1 listed)
- Symptoms associated with colorectal cancer (anemia, change of bowel habits, diarrhoea, constipation, haematochezia, weight loss, anorexia)
Key exclusion criteria (2 listed)
- Screening investigations
- High-risk patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fecal occult blood test | Device | – |
Primary outcome
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
1 secondary outcome
Number of patients with low fecal blood output in relation to colorectal polyps
Time frame: Up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 31906738Tsapournas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Olsson, MD, PhD principal investigator
Centre for Clinical research, Eskilstuna, Uppsala universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with high fecal blood output in relation to colorectal cancer (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02491593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.