RTGene

• Research type

  Research Study

• Full title

  Feasibility study testing multi-panel coding and non-coding transcriptional responses as an indicator of individualised responses to radiation effects in radiation therapy patients

• IRAS ID

  203547

• Contact name

  Navita Somaiah

• Contact email

  navita.somaiah@icr.ac.uk

• Sponsor organisation

  The Institute of Cancer Research

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Aim: The overall aim of this project is to develop existing knowledge on transcriptional responses to ionising radiation into a useable radiation specific biomarker of exposure and response.

  Patients: 20 patients over the age of 18 who require radiotherapy for breast, lung, gastrointestinal or genitourinary cancer and give written informed consent to participate will be included in the study.
  
  Recruitment: Eligible volunteers will be identified in the Outpatient Department at The Royal Marsden in Sutton or London and given a copy of the Patient Information Sheet describing the study in detail. Dr Somaiah’s team will call potential volunteers at least 24 hours after they have received written information about the study to answer any questions. If they agree to participate, they will be asked for their written consent and allocated a study ID. This will be used on all trial documentation and blood samples together with their date of birth and date of data/sample collection.

  Blood collection: 5 blood samples will be collected from each patient at the following time points during their radiotherapy: before 1st treatment, 30-90 minutes after 1st treatment, 24 hours after 1st treatment, before 5th or 6th treatment and before last treatment.

  Blood samples: the samples will be coded as described above and transferred to Public Health England’s laboratories in Didcot for processing and analyses. Any unused material will be returned to The Institute of Cancer Research and stored for future research.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  16/SC/0307

• Date of REC Opinion

  26 May 2016

• REC opinion

  Favourable Opinion