CancerRTGeneNCT02780375
Feasibility Study Testing Transcriptional Responses as an Indicator of Individualised Responses to Radiation Effects
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood donation during radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Sep 2016to 17 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing radiotherapy for cancer
Who may be able to join
- Age ≥18 years
- Requirement for external beam radiotherapy for breast, lung, gastrointestinal or genitourinary tumours
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
Biological markers of radiation exposure play a crucial role in the triage of suspected exposed persons following a radiation accident or incident. They can also estimate individual doses that enable assessment of late radiation effects in affected individuals. In recent years the gene expression assay has been shown to be a sensitive biological marker of radiation exposure with the potential to be used for truly individualised dosimetry. The possibility for this gene expression assay to be used in a large scale mass-casualty scenario has been proposed and tested in a recent intercomparison exercise. Classic cytogenetic techniques, and in particular the gold standard dicentric assay, have two main disadvantages: (1) lack of high-throughput and (2) delays of several days between blood sampling and the availability of results. Although more work needs to be done to further assess its suitability for triage purposes, it is clear that gene expression analysis in blood samples can provide valuable information, as there is a window of time (i.e. 12-48 hours) following radiation exposure where specific radiation-responsive genes have linear dose responses (0-5 Gy). Most work to date has focused on developing sensitive assays for studying gene expression modifications using state of the art technology, i.e. multiplex quantitative, digital polymerase chain reaction (qPCR) and molecular counting systems.
At Public Health England (PHE), recently established technology allows direct counting of nucleic acid molecules (DNA, mRNA, miRNA and lncRNA) without the need for enzymatic reaction or amplification steps hence reducing time for data collection. The system offers multiplexing capacity comparable to microarrays but with greater precision and sensitivity. Another unique advantage of this technology is that there is no need for long, time consuming bioinformatic analyses as the results are obtained as counted number of events. This new gene expression analysis technique has been assessed for radiation biodosimetry applications with promising results. Furthermore, gene expression has shown a high degree of promise as a marker for late effects of radiation, for instance normal tissue reactions following curative radiotherapy for breast cancer. Clinical data suggest that systemic inflammatory responses plays a critical role in the progression of radiation effects: for instance, the neutrophil-to-lymphocyte ratio represents a marker of systemic inflammation pre-treatment and is an independent prognostic factor useful for individual risk assessment in breast cancer patients undergoing radiotherapy. Genes relevant to inflammatory responses are thus interesting candidates for further investigation. Linearity of the transcriptional dose-response for specific radiation-responsive genes in ex vivo exposed human blood samples has recently been demonstrated for the first time, and inter-individual variability in the response after low doses and high doses exposures has been newly assessed. The logical next stage for biological development of the gene expression assay is to validate these new techniques with human blood samples exposed to radiation in vivo.
The use of samples from patients undergoing radiotherapy for validation of techniques has been gaining popularity in recent years. Sophisticated treatment planning for clinical radiotherapy leads to very accurate individual dose calculations that allow for validation of biological estimates of dose. The range of standard radiotherapy schedules chosen for inclusion in this study will provide a wide range of doses for assessment of the gene expression assay alone and in combination with the other cytogenetic assays, to simulate a range of potential exposure scenarios.
Peripheral blood samples will be taken with informed consent from patients undergoing standard radiotherapy 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 PHE, Columbia 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
- Cancer
- Being tested
- Blood donation during radiotherapy
- Keywords
- Transcriptional Responses, Radiation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood donation during radiotherapyProcedure or surgery
Participants will be asked to donate a blood sample at 5 time points before and during their radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Blood donation during radiotherapy | Participants will be asked to donate a blood sample at 5 time points before and during their radiotherapy Receives: Procedure: Blood donation during radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptional responses as measured by nCounter molecular profiling as biomarker of individual radiation exposure
Measured: 3 months after all volunteers have finished radiotherapy and donated blood samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start12 Sep 2016
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England
- Responsible party
- Sponsor
- Investigators
- Navita Somaiah, Principal investigator, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780375
- Sponsor's protocol ID
- CCR4553
- Acronym
- RTGene
- Status last verified
- Oct 2018
- First submitted
- 13 May 2016
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lloyd, D.C. and A.A. Edwards, Biological dosimetry after radiation accidents. In: G. Obe et al.,(eds). Chromosomal Aberrations. Springer-Verlag, Berlin, Heidelberg. 1990.
Maznik, 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.
Kabacik 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.
PubMed 21067298Manning 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.
PubMed 23362884Kabacik 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.
PubMed 21389785Badie 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.
PubMed 23886340Ainsbury 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.
PubMed 21183550Kabacik S, Manning G, Raffy C, Bouffler S, Badie C. Time, dose and ataxia telangiectasia mutated (ATM) status dependency of coding and noncoding RNA expression after ionizing radiation exposure. Radiat Res. 2015 Mar;183(3):325-37. doi: 10.1667/RR13876.1. Epub 2015 Mar 4.
PubMed 25738893Manning, G., et al., Assessing a new gene expression analysis technique for radiation biodosimetry applications. Radiation Measurements, 2011. 46(9): p. 1014-1018.
Finnon P, Kabacik S, MacKay A, Raffy C, A'Hern R, Owen R, Badie C, Yarnold J, Bouffler S. Correlation of in vitro lymphocyte radiosensitivity and gene expression with late normal tissue reactions following curative radiotherapy for breast cancer. Radiother Oncol. 2012 Dec;105(3):329-36. doi: 10.1016/j.radonc.2012.10.007. Epub 2012 Nov 15.
PubMed 23157981Krenn-Pilko S, Langsenlehner U, Stojakovic T, Pichler M, Gerger A, Kapp KS, Langsenlehner T. The elevated preoperative derived neutrophil-to-lymphocyte ratio predicts poor clinical outcome in breast cancer patients. Tumour Biol. 2016 Jan;37(1):361-8. doi: 10.1007/s13277-015-3805-4. Epub 2015 Jul 29.
PubMed 26219894Chua ML, Horn S, Somaiah N, Davies S, Gothard L, A'Hern R, Yarnold J, Rothkamm K. DNA double-strand break repair and induction of apoptosis in ex vivo irradiated blood lymphocytes in relation to late normal tissue reactions following breast radiotherapy. Radiat Environ Biophys. 2014 May;53(2):355-64. doi: 10.1007/s00411-014-0531-z. Epub 2014 Mar 13.
PubMed 24622963Chua ML, Somaiah N, A'Hern R, Davies S, Gothard L, Yarnold J, Rothkamm K. Residual DNA and chromosomal damage in ex vivo irradiated blood lymphocytes correlated with late normal tissue response to breast radiotherapy. Radiother Oncol. 2011 Jun;99(3):362-6. doi: 10.1016/j.radonc.2011.05.071. Epub 2011 Jun 23.
PubMed 21704405Chua ML, Somaiah N, Bourne S, Daley F, A'hern R, Nuta O, Davies S, Herskind C, Pearson A, Warrington J, Helyer S, Owen R, Yarnold J, Rothkamm K. Inter-individual and inter-cell type variation in residual DNA damage after in vivo irradiation of human skin. Radiother Oncol. 2011 May;99(2):225-30. doi: 10.1016/j.radonc.2011.04.009. Epub 2011 May 26.
PubMed 21620495Prise KM, O'Sullivan JM. Radiation-induced bystander signalling in cancer therapy. Nat Rev Cancer. 2009 May;9(5):351-60. doi: 10.1038/nrc2603. Epub 2009 Apr 20.
PubMed 19377507
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02780375
- Acronym / sponsor ID
- RTGene / CCR4553
- Conditions
- Cancer
- Keywords
- Transcriptional Responses, Radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Public Health England
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Biological markers of radiation exposure play a crucial role in the triage of suspected exposed persons following a radiation accident or incident. They can also estimate individual doses that enable assessment of late radiation effects in affected individuals. In recent years the gene expression assay has been shown to be a sensitive biological marker of radiation exposure with the potential to be used for truly individualised dosimetry. The possibility for this gene expression assay to be used in a large scale mass-casualty scenario has been proposed and tested in a recent intercomparison exercise. Classic cytogenetic techniques, and in particular the gold standard dicentric assay, have two main disadvantages: (1) lack of high-throughput and (2) delays of several days between blood sampling and the availability of results. Although more work needs to be done to further assess its suitability for triage purposes, it is clear that gene expression analysis in blood samples can provide valuable information, as there is a window of time (i.e. 12-48 hours) following radiation exposure where specific radiation-responsive genes have linear dose responses (0-5 Gy). Most work to date has focused on developing sensitive assays for studying gene expression modifications using state of the art technology, i.e. multiplex quantitative, digital polymerase chain reaction (qPCR) and molecular counting systems.
At Public Health England (PHE), recently established technology allows direct counting of nucleic acid molecules (DNA, mRNA, miRNA and lncRNA) without the need for enzymatic reaction or amplification steps hence reducing time for data collection. The system offers multiplexing capacity comparable to microarrays but with greater precision and sensitivity. Another unique advantage of this technology is that there is no need for long, time consuming bioinformatic analyses as the results are obtained as counted number of events. This new gene expression analysis technique has been assessed for radiation biodosimetry applications with promising results. Furthermore, gene expression has shown a high degree of promise as a marker for late effects of radiation, for instance normal tissue reactions following curative radiotherapy for breast cancer. Clinical data suggest that systemic inflammatory responses plays a critical role in the progression of radiation effects: for instance, the neutrophil-to-lymphocyte ratio represents a marker of systemic inflammation pre-treatment and is an independent prognostic factor useful for individual risk assessment in breast cancer patients undergoing radiotherapy. Genes relevant to inflammatory responses are thus interesting candidates for further investigation. Linearity of the transcriptional dose-response for specific radiation-responsive genes in ex vivo exposed human blood samples has recently been demonstrated for the first time, and inter-individual variability in the response after low doses and high doses exposures has been newly assessed. The logical next stage for biological development of the gene expression assay is to validate these new techniques with human blood samples exposed to radiation in vivo.
The use of samples from patients undergoing radiotherapy for validation of techniques has been gaining popularity in recent years. Sophisticated treatment planning for clinical radiotherapy leads to very accurate individual dose calculations that allow for validation of biological estimates of dose. The range of standard radiotherapy schedules chosen for inclusion in this study will provide a wide range of doses for assessment of the gene expression assay alone and in combination with the other cytogenetic assays, to simulate a range of potential exposure scenarios.
Peripheral blood samples will be taken with informed consent from patients undergoing standard radiotherapy 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 PHE, Columbia 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood donation during radiotherapy | – | Procedure: Blood donation during radiotherapyParticipants will be asked to donate a blood sample at 5 time points before and during their radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radiotherapy for cancer
Key inclusion criteria (3 listed)
- Age ≥18 years
- Requirement for external beam radiotherapy for breast, lung, gastrointestinal or genitourinary tumours
- Written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood donation during radiotherapyParticipants will be asked to donate a blood sample at 5 time points before and during their radiotherapy | Procedure or surgery | Blood donation during radiotherapy |
Primary outcome
Transcriptional responses as measured by nCounter molecular profiling as biomarker of individual radiation exposure
Time frame: 3 months after all volunteers have finished radiotherapy and donated blood samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- 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.
- Background: PubMed 21067298Kabacik 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.
- Background: PubMed 23362884Manning 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.
- Background: PubMed 21389785Kabacik 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.
- Background: PubMed 23886340Badie 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.
- Background: PubMed 21183550Ainsbury 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.
- Background: PubMed 25738893Kabacik S, Manning G, Raffy C, Bouffler S, Badie C. Time, dose and ataxia telangiectasia mutated (ATM) status dependency of coding and noncoding RNA expression after ionizing radiation exposure. Radiat Res. 2015 Mar;183(3):325-37. doi: 10.1667/RR13876.1. Epub 2015 Mar 4.
- BackgroundManning, G., et al., Assessing a new gene expression analysis technique for radiation biodosimetry applications. Radiation Measurements, 2011. 46(9): p. 1014-1018.
- Background: PubMed 23157981Finnon P, Kabacik S, MacKay A, Raffy C, A'Hern R, Owen R, Badie C, Yarnold J, Bouffler S. Correlation of in vitro lymphocyte radiosensitivity and gene expression with late normal tissue reactions following curative radiotherapy for breast cancer. Radiother Oncol. 2012 Dec;105(3):329-36. doi: 10.1016/j.radonc.2012.10.007. Epub 2012 Nov 15.
- Background: PubMed 26219894Krenn-Pilko S, Langsenlehner U, Stojakovic T, Pichler M, Gerger A, Kapp KS, Langsenlehner T. The elevated preoperative derived neutrophil-to-lymphocyte ratio predicts poor clinical outcome in breast cancer patients. Tumour Biol. 2016 Jan;37(1):361-8. doi: 10.1007/s13277-015-3805-4. Epub 2015 Jul 29.
- Background: PubMed 24622963Chua ML, Horn S, Somaiah N, Davies S, Gothard L, A'Hern R, Yarnold J, Rothkamm K. DNA double-strand break repair and induction of apoptosis in ex vivo irradiated blood lymphocytes in relation to late normal tissue reactions following breast radiotherapy. Radiat Environ Biophys. 2014 May;53(2):355-64. doi: 10.1007/s00411-014-0531-z. Epub 2014 Mar 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navita Somaiah principal investigator
Institute of Cancer Research, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptional responses as measured by nCounter molecular profiling as biomarker of individual radiation exposure (time frame: 3 months after all volunteers have finished radiotherapy and donated blood samples). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02780375, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.