RDC-Bio

• Research type

  Research Study

• Full title

  Rapid Diagnostic Centre Biomarker Study

• IRAS ID

  306766

• Contact name

  Richard Lee

• Contact email

  richard.lee@rmh.nhs.uk

• Sponsor organisation

  Royal Marsden Hospital NHS Foundation trust

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Rapid Diagnostic Centres (RDCs) are cancer diagnosis pathways where patients with non-specific but concerning symptoms of cancer (NSCS) can access rapid multidisciplinary assessment and/or investigations. This is part of the efforts of the NHS to improve early cancer diagnosis in the UK, which has historically been poor compared to countries of similar socio-economic status with comparable healthcare systems.

  Those who present initially with NSCS are an important group to focus on as they are typically diagnosed with cancer at a later stage, potentially representing missed opportunities for diagnosis, and have worse outcomes.

  The primary aim of this study is to assess the predictive value of biomarkers for differentiating cancer or serious benign pathologies within an RDC setting using independent or combined analysis of:
  • Blood and non-blood biomarkers
  • Symptoms from paper or electronic survey
  • Routinely collected risk factor, clinical and imaging data
  • Baseline genetic risk for cancer

  Eligible patients shall include those seen in RDCs over 18 years of age, who have not been previously treated for or have a current diagnosis of active cancer prior to being seen in the RDC.

  For participants that have provided informed consent to be enrolled in the study they shall be administered a symptom questionnaire at initial contact with biomarker samples obtained where possible at the same time as routine clinical care (i.e. blood biomarkers are collected in additional blood sample bottles at time of routine blood tests arranged by the clinical team).

  By furthering the clinical validation of novel biomarkers this will help support each of the following objectives of RDCs in the future:
  • Support earlier and faster cancer diagnosis
  • Increase capacity through more efficient diagnostic pathways
  • Deliver a better, personalised diagnostic experience
  • Reduce unwarranted variation in referral for, access to and in the reliability of relevant diagnostic tests

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  22/PR/1107

• Date of REC Opinion

  19 Aug 2022

• REC opinion

  Favourable Opinion