Exploratory Study of Early Biomarkers Allowing Dynamic Assessment of Response to Treatment in Cancers of the Head and Neck

Обзор

DART is an exploratory molecular analysis study to assess potential early biomarkers of treatment response in squamous cell carcinoma of the head and neck (HNSCC)

Подробное описание

If cancer that starts in the head or neck is not suitable for surgery or radiotherapy, then it cannot be cured. Unfortunately, people in this situation have a short life expectancy, with half dying within 12 months. There are treatments available that have helped people in this situation live longer, most recently drugs that stimulate the body's own immune system to attack the cancer, known as 'immunotherapy'. Some people do very well on these treatments, living many years, while the same treatments offer no benefit to others - it is not known why. This study is looking at collecting samples of a person's cancer, along with other body fluids, particularly blood and saliva, to see if the investigators can track changes in blood and saliva that happen in a person's cancer while they are receiving treatment. Additionally, samples of the cancer will be used to see if they can be grown in the laboratory to test growth behaviour and how well different treatments work.

The investigators will ask people being treated for incurable cancer that started in the head and neck for permission to collect their blood and saliva, along with samples of their cancer tissue, while they are having treatment. Nearly all patients will require a sample of their cancer tissue taken with a needle (a 'biopsy') anyway, and tissue samples can be taken as part of this process. Similarly, the safe administration of cancer drugs requires blood tests before every course of treatment, and research bloods can be taken from the same blood draw. A small number of people will be asked whether they give their permission for an extra biopsy of their cancer to allow further comparisons in the laboratory.

Вмешательства

• Генная терапия Circulating tumour DNA dynamics
  Circulating tumour DNA (ctDNA) can be identified in patients with a wide variety of cancers and has been shown to allow early prediction of disease relapse after treatment with curative intent in HNSCC.

Первичные конечные точки

• The level of circulating tumour DNA pre-treatment will be descriptively compared to the levels detected at subsequent time points [Срок оценки: Through study completion, expected duration of 5 years]

Вторичные конечные точки (5)

• To collect longitudinal biological samples, including blood, saliva and tissue, for molecular profiling [Срок оценки: Through study completion, expected duration of 5 years]
• To collect tumour tissue to facilitate molecular analysis of recurrent or metastatic cancers of the head and neck. [Срок оценки: Through study completion, expected duration of 5 years]
• To isolate live tumour and immune cells for studies of therapy resistance and biology in cancers of the head and neck. [Срок оценки: Through study completion, expected duration of 5 years]
• Retrieval and analysis of archival primary tissue blocks for comparison with metastatic tumour sites. [Срок оценки: Through study completion, expected duration of 5 years]
• To correlate assays with clinicopathological data. [Срок оценки: Through study completion, expected duration of 5 years]

Критерии участия

Критерии включения

• Age 18 years or older
• Patients with histologically confirmed cancer of the head and neck with evidence of recurrent or locally advanced cancer not suitable for treatment with curative intent, or metastatic disease.
• Receiving immunotherapy
• Ability to give informed consent for biological sample collection.

Критерии исключения

• Unable to undergo serial sample collection
• Pregnancy

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

Публикации

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Идентификаторы

NCT: NCT05644457 · CCR5397

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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