Colorectal CancerNCT02037646
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral
A study testing Qualitative fecal immunochemical test, Quantitative fecal immunochemical test and Colonoscopy in people with Colorectal Cancer, run by University of Malaya at 1 site in Malaysia.
Trial summary
The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Qualitative fecal immunochemical test, Quantitative fecal immunochemical test and Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteMalaysia
- Study dates
- Jun 2012to Dec 2016
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 50 years and above
Who cannot join
- Lower gastrointestinal tract symptoms such as diarrhoea, constipation, per rectal bleeding
- Personal history of colorectal tumour or cancer
- Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of Screening Strategies Using Quantitative Versus Qualitative Fecal Immunochemical Test (FIT) to Prioritize Urgency of Colonoscopy Referral - a Randomized Controlled Trial Protocol
The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral).
Read the detailed description
It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.
- Conditions
- Colorectal Cancer
- Being tested
- Qualitative fecal immunochemical test, Quantitative fecal immunochemical test, Colonoscopy, Cost analysis, Anxiety scores
- Keywords
- Colorectal cancer, Screening, Fecal occult blood, Fecal immunochemical test, Qualitative, Quantitative
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative fecal immunochemical testOther
This test measures the amount of blood within the submitted stool specimen
Quantitative fecal immunochemical testOther
This test detects presence or absence of blood within a submitted stool specimen.
ColonoscopyProcedure or surgery
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
Cost analysisOther
Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Anxiety scoresOther
Hospital Anxiety and Depression Scale (HADS) questionnaire
Patient satisfaction scoresOther
A 5-point patient satisfaction score will be documented at each patient visit related to screening.
| Study group | Role | What they receive |
|---|---|---|
| Qualitative fecal immunochemical test | Other | Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients. Receives: Other: Qualitative fecal immunochemical test; Procedure: Colonoscopy; Other: Cost analysis; Other: Anxiety scores; Other: Patient satisfaction scores |
| Quantitative fecal immunochemical test | Other | Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients. Receives: Other: Quantitative fecal immunochemical test; Procedure: Colonoscopy; Other: Cost analysis; Other: Anxiety scores; Other: Patient satisfaction scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis of advanced colorectal neoplasms
Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm
Measured: 40-90 days from the time of enrolment
Secondary outcomes (2)
Analysis of screening costs
Total costs incurred as a result of the screening process
Measured: Up to 90 days following enrolment
Patient anxiety levels
As measured by the Hospital Anxiety and Depression Scale (HADS)
Measured: Up to 90 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJun 2012
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- April C Roslani, MBBCh, Principal investigator, University of Malaya Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037646
- Sponsor's protocol ID
- 926.24
- Status last verified
- Oct 2017
- First submitted
- 14 Jan 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Screening Strategies Using Quantitative Versus Qualitative Fecal Immunochemical Test (FIT) to Prioritize Urgency of Colonoscopy Referral - a Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT02037646
- Acronym / sponsor ID
- 926.24
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Screening, Fecal occult blood, Fecal immunochemical test, Qualitative, Quantitative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Jan 2014 (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 main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral).
Detailed description
It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualitative fecal immunochemical test | Other | Other: Qualitative fecal immunochemical test, Procedure: Colonoscopy, Other: Cost analysis, Other: Anxiety scores, Other: Patient satisfaction scoresStool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows: >200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients. |
| Quantitative fecal immunochemical test | Other | Other: Quantitative fecal immunochemical test, Procedure: Colonoscopy, Other: Cost analysis, Other: Anxiety scores, Other: Patient satisfaction scoresStool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows: Positive - colonoscopy as per waiting list Negative - no colonoscopy Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 50 years and above
Key exclusion criteria (3 listed)
- Lower gastrointestinal tract symptoms such as diarrhoea, constipation, per rectal bleeding
- Personal history of colorectal tumour or cancer
- Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
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 |
|---|---|---|
| Qualitative fecal immunochemical testThis test measures the amount of blood within the submitted stool specimen | Other | Qualitative fecal immunochemical test |
| Quantitative fecal immunochemical testThis test detects presence or absence of blood within a submitted stool specimen. | Other | Quantitative fecal immunochemical test |
| ColonoscopyPatients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms. | Procedure or surgery | Qualitative fecal immunochemical test, Quantitative fecal immunochemical test |
| Cost analysisData on direct and indirect costs to patient and institution will be collected at each patient visit related to screening. | Other | Qualitative fecal immunochemical test, Quantitative fecal immunochemical test |
| Anxiety scoresHospital Anxiety and Depression Scale (HADS) questionnaire | Other | Qualitative fecal immunochemical test, Quantitative fecal immunochemical test |
| Patient satisfaction scoresA 5-point patient satisfaction score will be documented at each patient visit related to screening. | Other | Qualitative fecal immunochemical test, Quantitative fecal immunochemical test |
Primary outcome
Time to diagnosis of advanced colorectal neoplasms
Time frame: 40-90 days from the time of enrolment
Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm
2 secondary outcomes
Analysis of screening costs
Time frame: Up to 90 days following enrolment
Patient anxiety levels
Time frame: Up to 90 days after enrolment
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 27 Oct 2017.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
April C Roslani, MBBCh principal investigator
University of Malaya Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative fecal immunochemical test, Quantitative fecal immunochemical test and Colonoscopy in people with Colorectal Cancer, run by University of Malaya at 1 site in Malaysia.
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 3 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 27 Oct 2017. 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 Malaysia. 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?
Time to diagnosis of advanced colorectal neoplasms (time frame: 40-90 days from the time of enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2017.