Colorectal CancerNCT05156307
Accuracy and Predictive Values for Colorectal Cancer of Quantitative FIT in Symptomatic Patients in Primary Care
An observational study of Colorectal Cancer, run by Region Örebro County at 1 site in Sweden.
Trial summary
The aim of this study is to determine accuracy and predictive values for colorectal cancer of a faecal quantitative immunochemical test (FIT) in unselected symptomatic patients presenting in primary care. Main reference test will be linkage to a nationwide colorectal cancer registry. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 2,500 participants
- Where
- 1 siteSweden
- Study dates
- 20 May 2021to Jun 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥ 40 years presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible. This involves referral for any endoscopic or radiological examination of the large bowel, laboratory testing, including faecal occult blood test according to local routines, or clinical follow-up within soon. Both urgent referrals and patients planned for at least initial management in primary care are eligible, ie there will be no attempt to delimitate the study population based on any categorization of symptoms into "alarm" and "non-alarm" symptoms. The study population will be defined by primary care physicians´ clinical reasoning and assessment of colorectal cancer as a (more or less) possible diagnosis at the unique consultation.
Who may be able to join
- Patients presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible.
Who cannot join
- Referral for bowel examination for other reasons than symptoms. Not able to understand the instructions for participation.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skebäcks VC
Örebro, 702 15
Anna Lööv, MD, +46735454965, anna.loov@regionorebrolan.se
About this study
Official title: Accuracy and Predictive Values for Colorectal Cancer of a Quantitative Faecal Immunochemical Test in Symptomatic Patients in Primary Care
The aim of this study is to determine accuracy and predictive values for colorectal cancer of a faecal quantitative immunochemical test (FIT) in unselected symptomatic patients presenting in primary care. Main reference test will be linkage to a nationwide colorectal cancer registry.
Read the detailed description
This is a nationwide multi-centre study in primary care, Sweden. Patients from the age of 40 years and above presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible.
Consenting patients will fill out a short form on symptoms during last 4 weeks. They will provide 2 faecal samples from 2 different days. Samples will be analysed at any of three laboratories within 5 days using QuikRead go® (Aidian Oy). The analytical working range is 10-200 µg Hb/g faeces. The outcome will be reported as the concentration of first test (FIT 1) and highest concentration of two tests (FIT max). The outcome of the study FIT will remain within the study and GPs must request a separate FOBT for clinical purposes.
Reference test will be linkage to the Swedish Colorectal Cancer Registry (with in practice complete coverage) after at most 2 years for all patients. Accuracy and predictive values will be determined and ROC-curves analysed.
Some patients included in the study will be referred for colonoscopy for clinical reasons, and the outcome of FIT in relation to colonoscopy findings will be reported for this group as well.
- Conditions
- Colorectal Cancer
- Keywords
- Quantitative faecal immunochemical test, symptomatic, primary care
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer
Linkage to cancer registry
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start20 May 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (estimated)
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 CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Region Jämtland Härjedalen, Region Östergötland, Uppsala County Council, Sweden, Dalarna County Council, Sweden, Landstinget i Värmland
- Responsible party
- Principal investigator, Louise Olsson, Region Örebro County
- Investigators
- Louise Olsson, MD, PhD, Principal investigator, Region Örebro län, Camtö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156307
- Sponsor's protocol ID
- 275691
- Status last verified
- Nov 2021
- First submitted
- 1 Dec 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loov A, Hogberg C, Lilja M, Theodorsson E, Hellstrom P, Metsini A, Olsson L. Diagnostic accuracy for colorectal cancer of a quantitative faecal immunochemical test in symptomatic primary care patients: a study protocol. Diagn Progn Res. 2022 Aug 18;6(1):16. doi: 10.1186/s41512-022-00129-7.
PubMed 35978403
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Predictive Values for Colorectal Cancer of a Quantitative Faecal Immunochemical Test in Symptomatic Patients in Primary Care
- ClinicalTrials.gov ID
- NCT05156307
- Acronym / sponsor ID
- 275691
- Conditions
- Colorectal Cancer
- Keywords
- Quantitative faecal immunochemical test, symptomatic, primary care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Region Jämtland Härjedalen, Region Östergötland, Uppsala County Council, Sweden, Dalarna County Council, Sweden, Landstinget i Värmland
- Study start
- 20 May 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 14 Dec 2021 (actual)
- 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 determine accuracy and predictive values for colorectal cancer of a faecal quantitative immunochemical test (FIT) in unselected symptomatic patients presenting in primary care. Main reference test will be linkage to a nationwide colorectal cancer registry.
Detailed description
This is a nationwide multi-centre study in primary care, Sweden. Patients from the age of 40 years and above presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible.
Consenting patients will fill out a short form on symptoms during last 4 weeks. They will provide 2 faecal samples from 2 different days. Samples will be analysed at any of three laboratories within 5 days using QuikRead go® (Aidian Oy). The analytical working range is 10-200 µg Hb/g faeces. The outcome will be reported as the concentration of first test (FIT 1) and highest concentration of two tests (FIT max). The outcome of the study FIT will remain within the study and GPs must request a separate FOBT for clinical purposes.
Reference test will be linkage to the Swedish Colorectal Cancer Registry (with in practice complete coverage) after at most 2 years for all patients. Accuracy and predictive values will be determined and ROC-curves analysed.
Some patients included in the study will be referred for colonoscopy for clinical reasons, and the outcome of FIT in relation to colonoscopy findings will be reported for this group as well.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 40 years presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible. This involves referral for any endoscopic or radiological examination of the large bowel, laboratory testing, including faecal occult blood test according to local routines, or clinical follow-up within soon. Both urgent referrals and patients planned for at least initial management in primary care are eligible, ie there will be no attempt to delimitate the study population based on any categorization of symptoms into "alarm" and "non-alarm" symptoms. The study population will be defined by primary care physicians´ clinical reasoning and assessment of colorectal cancer as a (more or less) possible diagnosis at the unique consultation.
Key inclusion criteria (1 listed)
- Patients presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible.
Key exclusion criteria (1 listed)
- Referral for bowel examination for other reasons than symptoms. Not able to understand the instructions for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Colorectal cancer
Time frame: 2 years
Linkage to cancer registry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Derived from this study: PubMed 35978403Loov A, Hogberg C, Lilja M, Theodorsson E, Hellstrom P, Metsini A, Olsson L. Diagnostic accuracy for colorectal cancer of a quantitative faecal immunochemical test in symptomatic primary care patients: a study protocol. Diagn Progn Res. 2022 Aug 18;6(1):16. doi: 10.1186/s41512-022-00129-7.
- Individual participant dataSharing planned: No
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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
Region Örebro län, Camtö
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 Cancer, run by Region Örebro County 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 1 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: status not confirmed, as of the sponsor's last update on 14 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Lööv, MD (+46735454965, anna.loov@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer (time frame: 2 years). 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 NCT05156307, 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 14 Dec 2021.