Use of Phase 2 Clinical Trial Samples for RNA NGS Assay Development

• Research type

  Research Study

• Full title

  A non-interventional, retrospective study for the testing of RNA extracted from whole blood samples, derived from patients that participated in a phase 2 clinical trial. The therapeutic is a synthetic DNA vaccine targeting human papillomavirus (HPV) 16 and 18 for cervical intraepithelial neoplasia (CIN) grade 2/3. The results from this study will be used to determine if RNAs that can predict drug response can be detected and used to accurately stratify patients into responders and non-responders to the pharma partner's drug.

• IRAS ID

  298142

• Contact name

  Nathan Dennison

• Contact email

  Nathan.Dennison@qiagen.com

• Sponsor organisation

  QIAGEN

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  Research Summary:
  QIAGEN have partnered with a Pharma Partner to develop a medical diagnostic that may detect important RNAs in patients with pre-cancerous lesions due to Human Papilloma Virus (HPV) infection. This is done in order to improve treatment of the pre-cancerous lesions, detection of the RNAs can help to inform treatment with a drug from the Pharma Partner. This is a retrospective study and will evaluate the proposed medical device in a research setting. The device consists of Next Generation Sequencing (NGS), a technology that can sequence all RNAs within a patient sample in one test. Study samples, plasma collected from individuals with the pre-cancerous lesions, will be used to determine if the NGS workflow is able to stratify patients into responders or non-responders. Subsequently, the study will then test how much RNA is required to accurately stratify patients by sequencing varying amount of NGS library (an NGS Library is a sample prepared in a form ready for sequencing). The clinical samples were previously collected in a Phase 2 clinical trial and consent is in place to test samples in future research. The samples will be imported as plasma from the Pharma Partner in the USA in anonymized form and material transfer is covered by a contract termed 'Master Collaboration Agreement' in place between QIAGEN and the Pharma Partner. The study will be performed at QIAGEN Manchester and is expected to last for up to 18 months.

  Lay Summary of Results:
  During the course of the planned study, we were notified that the sample material (plasma) being used as part of the retrospective study was a non-notifiable material and therefor did not require REC approval for its use. As per guidance provided by email from the REC, this final report is being completed to state that the study has concluded and that REC approval was not actually required in the first instance

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/PR/0716

• Date of REC Opinion

  1 Jun 2021

• REC opinion

  Favourable Opinion