SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues

Обзор

Recently technology has been developed at the Wellcome Sanger Institute to allow clusters of cells with mutations to be detected in normal and diseased tissues. The researchers wish to determine how the number and nature of these mutant cell clusters change in response to treatments given to cancer patients (such as chemotherapy, radiotherapy, immunotherapy, and drugs targeted at specific mutations in tumours). As such the researchers wish to collect research samples of blood, cheek cells (via swabs) and urine from adult cancer patients receiving the above-mentioned treatments as part of their standard care. The researchers also wish to access any leftover tissue following surgery that is undertaken as part of these patient's treatment.

Подробное описание

Disease and tissue aging are thought to be influenced by genetic changes, or mutations, acquired throughout life. These mutations provide clues regarding the genetic damage that occurred through the lifetime of the patient, and include mutations caused by environmental factors such as ultraviolet light from sunlight or tobacco smoke affecting the skin or internal tissues, respectively. Other mutations may occur due to errors in copying the genome as cells divide. Once a cell has acquired a mutation, the cell's daughters may inherit it. Eventually clusters of cells carrying the same mutation may form within tissues. If the mutations alter cell behaviour this may impact how cells behave and influence how a whole tissue functions.

Вмешательства

• Другое sample collection
  Participants may collected their own cheek swabs and will collect their own urine samples. Clinical professionals at participating sites will collect blood samples.
• Другое Discussing study
  Research Nurse/ Suitably qualified Research Site Staff will discuss the study with potential participants
• Другое Seeking consent
  Potential participants who wish to give consent will do with a Research Nurse/ Suitably qualified Research Site Staff.

Первичные конечные точки

• To measure the frequency of acquired (somatic) mutations [Срок оценки: 5 years]
• To measure the size of acquired (somatic) mutations [Срок оценки: 5 years]

Вторичные конечные точки (1)

• To understand the nature of acquired (somatic) mutations [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Male or Female
• Due to commence systemic treatment for histologically confirmed cancer at a - participating site
• Age over 18 years
• Able to give informed consent.
• Able to give urine, blood and cheek swab samples on two occasions.
• Likely to complete 3 months of treatment

Критерии исключения

• Anyone outside of the inclusion criteria plus individuals who Lack the capacity to provide informed consent and those who do not have a good command of the English language.
• Any participant who is known to have Hep B, Hep C or HIV

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Великобритания · 1 центр

• Wellcome Sanger Institute — Cambridge

Идентификаторы

NCT: NCT06832150 · 341204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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