The Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Location status: Recruiting
Location contact
Prof Vinidh Paleri
CONTACT
NCT Number: NCT04671940
Radical radiotherapy for head and neck squamous cell cancer (HNSCC) can be administered to primary disease with curative intent. Residual disease, recurrence or further tumours may subsequently occur in this irradiated field. It is unknown whether these cancers reflect primary resistance or represent the evolution of resistance on treatment.
Understanding this could allow stratification of patients to more effective primary treatments, such as transoral robotic surgery, or help tailor systemic therapies for these cancers in previously irradiated fields.
RECUT+ is an exploratory molecular analysis study to assess the selective impact of radiation therapy on HNSCC.
Participants will be recruited from the Royal Marsden Hospital (RMH), Chelsea, a tertiary referral H&N cancer unit in London, UK, specialising in transoral robotic surgery.
Retrospective participants will be identified from previous Head and neck MDT lists at RMH.
Prospective participants will be screened for by the RECUT+ team during the weekly H&N MDT meetings at the Royal Marsden Hospital (RMH).
Blood/saliva samples will be collected pre operatively (prospective participants) and post operatively (retrospective and prospective participants) for germline and circulating tumour DNA analysis.
Biopsy samples from the original cancer and resected specimens from the post radiotherapy residual/recurrent/new primary disease will undergo molecular analysis to assess for any selective impact of radiotherapy on these further tumours.
Interested in participating?
Request Info19 year and older
All sexes
Observational
London, SW3 6JJ, United Kingdom
Location status: Recruiting
Prof Vinidh Paleri
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Molecular analysis includes DNA analysis on the blood/saliva and on the cancer specimens from the biopsies & subsequent resections
Time frame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Identification of resistant sub clones in post radiotherapy tumour samples
Time frame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Identification of differences in sub clonal architecture of H&N SCC before and after radiotherapy.
Time frame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Identification of differences in mutational signatures between the primary disease and resistant sub clones.
Time frame: Within 1 year of surgery & receipt of blood/saliva and tissue samples
Identification of loss of heterozygosity at the HLA loci in resistant sub clones
Time frame: 5 years following the date of surgery of the final participant recruited.
Disease-specific and overall survival at 5 years related to identified molecular characteristics.
Contact information is provided by the study sponsor or research team.
Sarah Burton
CONTACT
Vishak C Muraleedharan Shylaja, MBChB
CONTACT
Royal Marsden NHS Foundation Trust
Other
RECUT PLUS: Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual/reCurrent Tumours of the Upper Aerodigestive Tract
Acronym: RECUT Plus
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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