NCT04671940 Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual/reCurrent Tumours of the Upper Aerodigestive Tract
| NCT ID | NCT04671940 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Head and Neck Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-11-18 |
| Primary Completion | 2026-10-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2020-11-18 with a primary completion date of 2026-10-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria * Aged over 18 * Previous H\&N cancer treated with radiotherapy. * Undergoing TORS as part of their management for residual, recurrent or new primary H\&N cancer. Exclusion criteria * Where TORS is used in a diagnostic setting only * Nasopharyngeal and thyroid head and neck cancers * Where no tissue specimens are available from the recurrent/residual/secondary tumour for the retrospective cohort
Contact & Investigator
Prof Vinidh Paleri
PRINCIPAL INVESTIGATOR
The Royal Marsden Hospital NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT04671940 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04671940 currently recruiting?
Yes, NCT04671940 is actively recruiting participants. Contact the research team at vishak.muraleedharanshylaja@rmh.nhs.uk for enrollment information.
Where is the NCT04671940 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT04671940 clinical trial?
NCT04671940 is sponsored by Royal Marsden NHS Foundation Trust. The principal investigator is Prof Vinidh Paleri at The Royal Marsden Hospital NHS Foundation Trust. The trial plans to enroll 20 participants.
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