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

Официальное название

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

Обзор

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.

Вмешательства

• Другое DNA Analysis
  Molecular analysis includes DNA analysis on the blood/saliva and on the cancer specimens from the biopsies \& subsequent resections

Первичные конечные точки

• Identification of resistant sub clones in post radiotherapy tumour samples [Срок оценки: Within 1 year of surgery & receipt of blood/saliva and tissue samples]

Вторичные конечные точки (4)

• Identification of differences in sub clonal architecture of H&N SCC before and after radiotherapy. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: Within 1 year of surgery & receipt of blood/saliva and tissue samples]
• Disease-specific and overall survival at 5 years related to identified molecular characteristics. [Срок оценки: 5 years following the date of surgery of the final participant recruited.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• The Royal Marsden Hospital — London

Идентификаторы

NCT: NCT04671940 · CCR 5263

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗