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PRedicting Outcomes For Crohn’s dIsease using a moLecular biomarkEr (PROFILE): protocol for a multicentre, randomised, biomarker-stratified trial
  1. Miles Parkes1,
  2. Nurulamin M Noor1,
  3. Francis Dowling2,
  4. Harvey Leung2,
  5. Simon Bond2,3,
  6. Lynne Whitehead4,
  7. Sara Upponi5,
  8. Paul Kinnon6,
  9. Andrew P Sandham6,
  10. Paul A Lyons1,6,
  11. Eoin F McKinney1,6,
  12. Kenneth G C Smith1,6,
  13. James C Lee1
  1. 1 Department of Medicine, University of Cambridge School of Clinical Medicine, Addenbrooke’s Hospital, Cambridge, UK
  2. 2 Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
  3. 3 Medical Research Council Biostatistics Unit, University of Cambridge, Cambridge, UK
  4. 4 Clinical Trials Pharmacy, Addenbrooke’s Hospital, Cambridge, UK
  5. 5 Department of Radiology, Addenbrooke’s Hospital, Cambridge, UK
  6. 6 PredictImmune Ltd, Babraham Research Campus, Cambridge, UK
  1. Correspondence to Dr Miles Parkes; miles.parkes{at}addenbrookes.nhs.uk and Dr James C Lee; jcl65{at}cam.ac.uk

Footnotes

  • MP and NMN contributed equally.

  • Contributors MP, NMN, FD, KGCS and JCL wrote the full trial protocol. HL, PK and APS reviewed and edited draft versions of the protocol. The Statistics and data analysis sections of the trial protocol were written by SB. LW contributed to the Trial treatment section of the protocol, and SU contributed to the Radiology section. PAL, EFM, MP, KGCS and JCL were the initiators of this trial. All authors took part in reading and final approval of the manuscript.

  • Funding This trial is funded by the Wellcome Trust via an investment in PredictImmune (200448/Z/16/Z). The Apex Healthcare Consulting survey and biomarker development work described herein was funded by a Wellcome Trust Interim Translational Award (099450/Z/12/Z). The trial is cosponsored by Cambridge University Hospitals NHS Foundation Trust and University of Cambridge. The sponsors are not involved in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. EFM and JCL are supported by Wellcome Trust Intermediate Clinical Fellowships (104064/Z/14/Z and 105920/Z/14/Z respectively).

  • Competing interests PAL, EFM, KGCS and JCL are coinventors on a patent covering the method of assessing prognosis in IBD. PAL, EFM and KGCS are cofounders and consultants for PredictImmune. PK and APS are employees of PredictImmune. JCL is a consultant for PredictImmune.

  • Patient consent Not required.

  • Ethics approval East of England Cambridge South Research Ethics Committee.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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Footnotes

  • MP and NMN contributed equally.

  • Contributors MP, NMN, FD, KGCS and JCL wrote the full trial protocol. HL, PK and APS reviewed and edited draft versions of the protocol. The Statistics and data analysis sections of the trial protocol were written by SB. LW contributed to the Trial treatment section of the protocol, and SU contributed to the Radiology section. PAL, EFM, MP, KGCS and JCL were the initiators of this trial. All authors took part in reading and final approval of the manuscript.

  • Funding This trial is funded by the Wellcome Trust via an investment in PredictImmune (200448/Z/16/Z). The Apex Healthcare Consulting survey and biomarker development work described herein was funded by a Wellcome Trust Interim Translational Award (099450/Z/12/Z). The trial is cosponsored by Cambridge University Hospitals NHS Foundation Trust and University of Cambridge. The sponsors are not involved in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. EFM and JCL are supported by Wellcome Trust Intermediate Clinical Fellowships (104064/Z/14/Z and 105920/Z/14/Z respectively).

  • Competing interests PAL, EFM, KGCS and JCL are coinventors on a patent covering the method of assessing prognosis in IBD. PAL, EFM and KGCS are cofounders and consultants for PredictImmune. PK and APS are employees of PredictImmune. JCL is a consultant for PredictImmune.

  • Patient consent Not required.

  • Ethics approval East of England Cambridge South Research Ethics Committee.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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