Clinical trial · Observational
Feasibility Study Testing Transcriptional Responses as an Indicator of Individualised Responses to Radiation Effects
Feasibility Study Testing Multi-panel Coding and Non-coding Transcriptional Responses as an Indicator of Individualised Responses to Radiation Effects in Radiation Therapy Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Peripheral blood samples will be taken with informed consent from radiotherapy patients undergoing standard radiotherapy at The Royal Marsden before and during treatment for breast, lung, gastrointestinal and genitourinary tumours. Responses from panels of up to 800 coding and non-coding RNAs will be assessed in the samples using the nCounter system. Candidate genes identified by Public Health England, Columbia University and/or in the literature as being specific to radiation responses will be included, together with genes relevant to systemic inflammatory 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 proposed pilot is expected in due course.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood donation during radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Blood donation during radiotherapy
- description
- Participants will be asked to donate a blood sample at 5 time points before and during their radiotherapy
- interventionNames
- Procedure: Blood donation during radiotherapy
Primary outcomes (1)
- measure
- Transcriptional responses as measured by nCounter molecular profiling as biomarker of individual radiation exposure
- timeFrame
- 3 months after all volunteers have finished radiotherapy and donated blood samples
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Requirement for external beam radiotherapy for breast, lung, gastrointestinal or genitourinary tumours * Written informed consent Exclusion Criteria: * Previous radiotherapy * Concurrent chemotherapy or chemotherapy preceding radiotherapy by less than 4 weeks * Concurrent hormone therapy or hormone therapy preceding radiotherapy by less than 4 weeks
References
Publications (15)
- BACKGROUNDLloyd, D.C. and A.A. Edwards, Biological dosimetry after radiation accidents. In: G. Obe et al.,(eds). Chromosomal Aberrations. Springer-Verlag, Berlin, Heidelberg. 1990.
- BACKGROUNDMaznik, N.A., et al., Chromosomal dosimetry for some groups of evacuees from Prypiat and Ukrainian liquidators at Chernobyl. Radiation Protection Dosimetry, 1997. 74(1-2): p. 5-11.
- BACKGROUNDKabacik S, Mackay A, Tamber N, Manning G, Finnon P, Paillier F, Ashworth A, Bouffler S, Badie C. Gene expression following ionising radiation: identification of biomarkers for dose estimation and prediction of individual response. Int J Radiat Biol. 2011 Feb;87(2):115-29. doi: 10.3109/09553002.2010.519424. Epub 2010 Nov 10. PMID 21067298
- BACKGROUNDManning G, Kabacik S, Finnon P, Bouffler S, Badie C. High and low dose responses of transcriptional biomarkers in ex vivo X-irradiated human blood. Int J Radiat Biol. 2013 Jul;89(7):512-22. doi: 10.3109/09553002.2013.769694. Epub 2013 Feb 27. PMID 23362884
- BACKGROUNDKabacik S, Ortega-Molina A, Efeyan A, Finnon P, Bouffler S, Serrano M, Badie C. A minimally invasive assay for individual assessment of the ATM/CHEK2/p53 pathway activity. Cell Cycle. 2011 Apr 1;10(7):1152-61. doi: 10.4161/cc.10.7.15231. Epub 2011 Apr 1. PMID 21389785
- BACKGROUNDBadie C, Kabacik S, Balagurunathan Y, Bernard N, Brengues M, Faggioni G, Greither R, Lista F, Peinnequin A, Poyot T, Herodin F, Missel A, Terbrueggen B, Zenhausern F, Rothkamm K, Meineke V, Braselmann H, Beinke C, Abend M. Laboratory intercomparison of gene expression assays. Radiat Res. 2013 Aug;180(2):138-48. doi: 10.1667/RR3236.1. Epub 2013 Jul 25. PMID 23886340
- BACKGROUNDAinsbury EA, Bakhanova E, Barquinero JF, Brai M, Chumak V, Correcher V, Darroudi F, Fattibene P, Gruel G, Guclu I, Horn S, Jaworska A, Kulka U, Lindholm C, Lloyd D, Longo A, Marrale M, Monteiro Gil O, Oestreicher U, Pajic J, Rakic B, Romm H, Trompier F, Veronese I, Voisin P, Vral A, Whitehouse CA, Wieser A, Woda C, Wojcik A, Rothkamm K. Review of retrospective dosimetry techniques for external ionising radiation exposures. Radiat Prot Dosimetry. 2011 Nov;147(4):573-92. doi: 10.1093/rpd/ncq499. Epub 2010 Dec 23.