RTGene 2

  • Research type

    Research Study

  • Full title

    Multi-panel coding and non-coding transcriptional responses as an indicator of individualised responses to radiation effects in radiation therapy patients

  • IRAS ID

    258794

  • Contact name

    Navita Somaiah

  • Contact email

    navita.somaiah@icr.ac.uk

  • Sponsor organisation

    The Institute of Cancer Research

  • Clinicaltrials.gov Identifier

    NCT03809377

  • Duration of Study in the UK

    3 years, 2 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: 25 patients over the age of 18 who require radiotherapy for sarcoma, breast, lung, gastrointestinal, gynaecological, head & neck or genitourinary tumours 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, 24 hours post 1st fraction (just before 2nd fraction), 24 hours post penultimate fraction (just before final fraction), 4 weeks post final fraction and 6 months post final fraction.

    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

    Wales REC 7

  • REC reference

    19/WA/0147

  • Date of REC Opinion

    8 May 2019

  • REC opinion

    Further Information Favourable Opinion