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Research

A novel blood based triage test for colorectal cancer in primary care: a pilot study

Cerys Jenkins, Freya Woods, Susan Chandler, Kym Carter, Rhys Jenkins, Andrew Cunningham, Kayleigh Nelson, Rachel Still, Jenna A Walters, Non Gwynn, Wilson Chea, Rachel Harford, Claire O'Neill, Julie Hepburn, Ian Hill, Heather Wilkes, Greg Fegan, Peter Dunstan and Dean A Harris
BJGP Open 13 December 2022; BJGPO.2022.0077. DOI: https://doi.org/10.3399/BJGPO.2022.0077
Cerys Jenkins
1 Physics Department, College of Science, Centre for NanoHealth, Swansea University, Swansea, UK
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Freya Woods
1 Physics Department, College of Science, Centre for NanoHealth, Swansea University, Swansea, UK
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Susan Chandler
2 Swansea University Medical School, Swansea University, Swansea, UK
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Kym Carter
2 Swansea University Medical School, Swansea University, Swansea, UK
3 Swansea Trials Unit, Swansea University, Swansea, UK
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Rhys Jenkins
1 Physics Department, College of Science, Centre for NanoHealth, Swansea University, Swansea, UK
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Andrew Cunningham
2 Swansea University Medical School, Swansea University, Swansea, UK
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Kayleigh Nelson
3 Swansea Trials Unit, Swansea University, Swansea, UK
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Rachel Still
4 Department of Laboratory Medicine, of Medical Biochemistry, Swansea Bay University Health Board, Swansea, UK
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Jenna A Walters
4 Department of Laboratory Medicine, of Medical Biochemistry, Swansea Bay University Health Board, Swansea, UK
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Non Gwynn
4 Department of Laboratory Medicine, of Medical Biochemistry, Swansea Bay University Health Board, Swansea, UK
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Wilson Chea
5 Department of Colorectal Surgery, Swansea Bay University Health Board, Swansea Bay University Health Board, Morriston Hospital, Swansea, UK
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Rachel Harford
6 Research and Development Department Swansea Bay University Health Board, Institute of Life Science 2, Swansea University, Swansea, UK
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Claire O'Neill
2 Swansea University Medical School, Swansea University, Swansea, UK
3 Swansea Trials Unit, Swansea University, Swansea, UK
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Julie Hepburn
7 Public Involvement Community, Health and Care Research Wales, Cardiff, UK
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Ian Hill
7 Public Involvement Community, Health and Care Research Wales, Cardiff, UK
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Heather Wilkes
8 Briton Ferry Primary Care Centre, Neath, UK
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Greg Fegan
2 Swansea University Medical School, Swansea University, Swansea, UK
3 Swansea Trials Unit, Swansea University, Swansea, UK
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Peter Dunstan
1 Physics Department, College of Science, Centre for NanoHealth, Swansea University, Swansea, UK
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Dean A Harris
5 Department of Colorectal Surgery, Swansea Bay University Health Board, Swansea Bay University Health Board, Morriston Hospital, Swansea, UK
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  • ORCID record for Dean A Harris
  • For correspondence: Dean.A.Harris@wales.nhs.uk
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    Figure 1. Study design. The mixed -methods prospective clinical validation study incorporated a retrospective cohort analysis to build the Raman-model, the prospective study for clinical validation, and a nested qualitative study for investigating attitudes of the test in primary care. USC = urgent suspected cancer; CRC = colorectal cancer. USC = urgent suspected cancer.
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    Figure 2. Disease prediction for the prospective validation cohort from secondary care urgent suspected cancer (USC) referral patients. Overall sensitivity, specificity, false negative rate, and false positive rate for the Raman-CRC model on a colonoscopy per-patient basis following blind analysis.

    CRC = colorectal cancer.

  • Figure 3.
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    Figure 3. Proposed new clinical pathway incorporating Raman-CRC testing as a triage tool in primary care. Symptomatic patients with a negative Raman-CRC test are reassured in primary care, relieving pressure on secondary care diagnostic services. The pathway could lead to earlier diagnosis and a reduction in time to treatment when a positive test is combined with a straight to test pathway. CRC = colorectal cancer.

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    Table 1. Disease prediction for the prospective validation cohort from secondary care USC referral patients. Test sensitivity and specificity (95% confidence intervals according to initial diagnostic test)
    n, totalSensitivitySpecificity
    Colonoscopy24895.7 (78.1% to 99.9%)69.3 (63.8% to 76.1%)
    Colonoscopy and CTC40589.7 (72.7% to 97.8%)65.7 (60.7% to 70.5%)
    • CTC = computed tomography colonoscopy. USC = urgent suspected cancer.

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    Table 2. Raman-CRC model performance for different cancer stages versus FIT
    Sensitivity for UICC guidance stages
    StageIIIIIIIV
    Raman-CRC50% (n = 4)90% (n = 10)100% (n = 12)100% (n = 3)
    FIT27 73% (65%–79%)80% (74%–84%)82% (77%–87%)79% (70%–86%)
    • CRC = colorectal cancer. FIT = faecal immunochemical test.

    • View popup
    Table 3. Comparison of Raman-CRC test performance with NG12 pathway and FIT
    NICE NG12 pathway3FIT (threshold 10 µg/g)7Raman-CRC
    Sensitivity9390.995.7
    Specificity3583.569.3
    AUCn/a0.930.8
    • AUC = area under curve. CRC = colorectal cancer. FIT = faecal immunochemical test. NICE = National Institute for Health and Care Excellence.

Supplementary Data

  • Harris_BJGPO.2022.0077_Supp.docx -

    Supplementary material is not copyedited or typeset, and is published as supplied by the author(s). The author(s) retain(s) responsibility for its accuracy.

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A novel blood based triage test for colorectal cancer in primary care: a pilot study
Cerys Jenkins, Freya Woods, Susan Chandler, Kym Carter, Rhys Jenkins, Andrew Cunningham, Kayleigh Nelson, Rachel Still, Jenna A Walters, Non Gwynn, Wilson Chea, Rachel Harford, Claire O'Neill, Julie Hepburn, Ian Hill, Heather Wilkes, Greg Fegan, Peter Dunstan, Dean A Harris
BJGP Open 13 December 2022; BJGPO.2022.0077. DOI: 10.3399/BJGPO.2022.0077

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A novel blood based triage test for colorectal cancer in primary care: a pilot study
Cerys Jenkins, Freya Woods, Susan Chandler, Kym Carter, Rhys Jenkins, Andrew Cunningham, Kayleigh Nelson, Rachel Still, Jenna A Walters, Non Gwynn, Wilson Chea, Rachel Harford, Claire O'Neill, Julie Hepburn, Ian Hill, Heather Wilkes, Greg Fegan, Peter Dunstan, Dean A Harris
BJGP Open 13 December 2022; BJGPO.2022.0077. DOI: 10.3399/BJGPO.2022.0077
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Keywords

  • colorectal neoplasms
  • two-week wait
  • pilot projects
  • qualitative research
  • Raman spectroscopy
  • primary health care
  • general practice

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