BEST3 - A trial of a new GP-based test for patients with heartburn symptoms | Recruiting
BEST3 - A trial of a new GP-based t... | Recruiting
BEST3 - A trial of a new GP-based test for patients with heartburn symptoms
BEST3

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Medical Conditions
  • Specialty: Primary Care, Primary sub-specialty: Cancer
  • UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of oesophagus, stomach and duodenum, Cancer/ Malignant neoplasms of lip, oral cavity and pharynx
Primary Contact Details
Ms Beth Muldrew
+44 (0)207 882 2932
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN68382401
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-the-cytosponge-test-in-gp-surgeries-for-people-with-heartburn-symptoms-best-3#undefined
Research Details
  • The aim of this study is to:
    1. Demonstrate that the invitation to the Cytosponge-TFF3 test leads to an increase in the number of patients diagnosed with Barrett’s oesophagus (BE) compared to the usual clinical care pathway in primary care
    2. Gain an in-depth understanding of the health economics of the Cytosponge -TFF3 test in patients on long-term treatment with acid suppressants as well as the economics for the projected reduction of cancer-related deaths
Phase
Sorry, this information is not available
Study Design
Randomised; Interventional; Design type: Diagnosis, Device, Management of Care
Study Type
Interventional
Intervention

120 practices will be randomised on a 1:1 basis to either the intervention or control arm. Practices will be randomised via block randomisation and be stratified by number of eligible patients. A cluster randomisation will be used to simplify research procedures and minimise impact of differing clinical practice within the same practice.

Intervention arm: Participants on long-term acid suppressant medication will receive the Cytosponge™ -TFF3 test and a clinically-indicated endoscopy where required and followed up at 12 months.

Control arm: Participants will receive usual care and followed up at 12 months.

Intervention Type
Other
Primary Outcome Measures
    Effectiveness is assessed using GP and hospital records of histologically-confirmed Barrett’s oesophagus at 12 months post GP recruitment.
Secondary Outcome Measures
    1. Cost-effectiveness is assessed using GP and hospital records to determine mean cost per patient receiving the Cytosponge™ -TFF3 test versus usual care and incremental cost per QALY gained of the Cytosponge™ TFF3 test versus usual care at 12 months post GP recruitment
    2. Patient acceptability is measured using a bespoke questionnaire at 7-14 days post procedure
    3. Accuracy is measured using Positive Predictive Value (PPV) and Negative Predictive Value (NPV) in relation to the length of BE at 12 months post GP recruitment
    4. Safety is measured using number of adverse events reported by patients up to 7 days post procedure
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 9000; UK Sample Size: 9000
Participant Inclusion Criteria
    1. Aged 50 years and over
    2. Records of at least six months of prescription for acid-suppressant medication in the last year
Participant Exclusion Criteria
    Current exclusion criteria as of 15/08/2017:
    1. Recorded regular prescriptions of NSAIDs
    2. Recorded upper GI endoscopy in the previous 5 years as identified from the practice database
    3. Recorded diagnosis of a current or previous oro-pharynx, oesophageal or gastro-oesophageal tumour
    4. Recorded diagnosis of Barrett’s oEsophagus (BE)
    5. Unable to attend the GP surgery
    6. Deemed not fit enough by their GP

    Previous exclusion criteria:
    1. Recorded regular prescriptions of NSAIDs
    2. Recorded regular prescription of Clopidogrel
    3. Recorded upper GI endoscopy in the previous 5 years as identified from the practice database
    4. Recorded diagnosis of a current or previous oro-pharynx, oesophageal or gastro-oesophageal tumour
    5. Recorded diagnosis of Barrett’s oEsophagus (BE)
    6. Unable to attend the GP surgery
    7. Deemed not fit enough by their GP
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
University of Cambridge
Cambridge
CB2 0XZ
London
EC1M 6BQ
Trial Contact(s)
Primary Trial Contact
Ms Beth Muldrew
+44 (0)207 882 2932
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Barrett’s oESophagus Trial 3 (BEST3): cluster randomised controlled trial comparing the Cytosponge™-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care.
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Cancer Research UK
Other Study ID Numbers
32540
Sponsor(s)
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Key Dates

Recruitment Start Date

15 Mar 2017

Recruitment End Date

01 May 2018

Trial Start Date

01 May 2016

Trial End Date

01 Sep 2019

Date added to source

19 Jan 2017

Date updated in source

15 Aug 2017