Transcriptional Responses as an Indicator of Individualised Responses to Radiation Effects (RTGene 2)

NCT03809377 | Active Not Recruiting

• 1 other identifier: IRAS258792
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral blood samples will be taken with informed consent from radiotherapy patients before and during treatment fractions for sarcoma, breast, lung, gut, genitourinary and head \& neck tumours at The Royal Marsden. Candidate genes identified by PHE, Columbia and/or in the literature as being specific to radiation responses will be assessed, together with genes relevant to systemic inflammatory and immune responses, to identify transcriptional responses for a range of doses and exposures on an inter-individual basis. Data will be analysed using existing and new statistical tools focused on count data modelling. The intended outcome is identification of a radiation specific panel of genes to inform individual radiation responses and if the results are favourable, a large scale follow up to this project is expected.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Validation of new transcriptional techniques

  Using nCounter platform to validate biomarkers of individual radiation exposure, in vivo

  24 months after all participants have finished radiotherapy and donated blood samples

Study Arms (1)

Blood donation during radiotherapy

Participants will be asked to donate a blood sample at 5 time points during and after radiotherapy

Procedure: Blood donation during radiotherapy

Interventions

Blood donation during radiotherapy PROCEDURE

Participants will be asked to donate a blood sample at 5 time points during and after radiotherapy

Blood donation during radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing radiotherapy for cancer

You may qualify if:

• Age ≥18 years
• Requirement for external beam radiotherapy (large-field RT, over at least 2 weeks) for sarcoma, breast, lung, gastrointestinal, head \& neck or genitourinary tumours
• Written informed consent

You may not qualify if:

• Previous radiotherapy
• Concurrent chemotherapy/biological therapy or chemotherapy/biological therapy preceding radiotherapy by less than 4 weeks
• Concurrent hormone therapy or hormone therapy preceding radiotherapy by less than 4 weeks

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Public Health England: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Navita Somaiah

  The Institute of Cancer Research, London, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 18, 2019
• Study Start: May 9, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

GB (1)