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Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual/reCurrent Tumours of the Upper Aerodigestive Tract

Sponsor: Royal Marsden NHS Foundation Trust

NCT ID: NCT04671940

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
DNA Analysis (other)
How long the study runs
Study runs about 71 months (dates as stated)
About the drug or intervention
DNA Analysis — other: Molecular analysis includes DNA analysis on the blood/saliva and on the cancer specimens from the biopsies \& subsequent resections
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
19 Years and over
Who
All
Number of participants
20
Started
2020-11-18
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for head and neck cancer
  • • Clinical study - 20 participants
  • • Radical radiotherapy for head and neck squamous cell cancer (HNSCC) can be administered to primary disease with curative intent

Who can take part?

  • • Ages 19 Years and over
  • • Diagnosed with head and neck cancer

Where?

  • • London - The Royal Marsden Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Head and Neck Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 19 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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
See the full 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

Where Is This Study? (1 UK site)

The Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Vishak C Muraleedharan Shylaja, MBChB

Sponsor contact

CONTACT

442073528171 vishak.muraleedharanshylaja@rmh.nhs.uk

Sarah Burton

Sponsor contact

CONTACT

020 8661 3567 sarah.burton@rmh.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-02