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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).
It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualitative fecal immunochemical test | Other | This test measures the amount of blood within the submitted stool specimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to diagnosis of advanced colorectal neoplasms | Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm | 40-90 days from the time of enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of screening costs | Total costs incurred as a result of the screening process | Up to 90 days following enrolment |
| Patient anxiety levels | As measured by the Hospital Anxiety and Depression Scale (HADS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| April C Roslani, MBBCh | University of Malaya Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
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| Quantitative fecal immunochemical test | Other | This test detects presence or absence of blood within a submitted stool specimen. |
|
| Colonoscopy | Procedure | Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms. |
|
| Cost analysis | Other | Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening. |
|
| Anxiety scores | Other | Hospital Anxiety and Depression Scale (HADS) questionnaire |
|
| Patient satisfaction scores | Other | A 5-point patient satisfaction score will be documented at each patient visit related to screening. |
|
| Up to 90 days after enrolment |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D003365 | Costs and Cost Analysis |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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