- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02037646
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral
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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Kuala Lumpur, Malaysia, 59100
- University of Malaya Medical Centre
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adults aged 50 years and above
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: Qualitative fecal immunochemical test
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. |
This test measures the amount of blood within the submitted stool specimen
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Hospital Anxiety and Depression Scale (HADS) questionnaire
A 5-point patient satisfaction score will be documented at each patient visit related to screening.
|
Övrig: Quantitative fecal immunochemical test
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. |
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Hospital Anxiety and Depression Scale (HADS) questionnaire
A 5-point patient satisfaction score will be documented at each patient visit related to screening.
This test detects presence or absence of blood within a submitted stool specimen.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to diagnosis of advanced colorectal neoplasms
Tidsram: 40-90 days from the time of enrolment
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Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm
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40-90 days from the time of enrolment
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Analysis of screening costs
Tidsram: Up to 90 days following enrolment
|
Total costs incurred as a result of the screening process
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Up to 90 days following enrolment
|
Patient anxiety levels
Tidsram: Up to 90 days after enrolment
|
As measured by the Hospital Anxiety and Depression Scale (HADS)
|
Up to 90 days after enrolment
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: April C Roslani, MBBCh, University of Malaya Medical Centre
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 926.24
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