SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sample collection, Discussing study, Seeking consent.
- Who it may be relevant to
- Registry conditions: Somatic Mutation, Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Other 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. - Other Discussing study
Research Nurse/ Suitably qualified Research Site Staff will discuss the study with potential participants - Other Seeking consent
Potential participants who wish to give consent will do with a Research Nurse/ Suitably qualified Research Site Staff.
Primary outcome measures
- To measure the frequency of acquired (somatic) mutations [Time frame: 5 years]
- To measure the size of acquired (somatic) mutations [Time frame: 5 years]
Secondary outcome measures (1)
- To understand the nature of acquired (somatic) mutations [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United Kingdom · 1 center
- Wellcome Sanger Institute — Cambridge
Identifiers
NCT: NCT06832150 · 341204