Clinical trial NCT06832150: SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues
Official title: SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Somatic Mutation
Cancer
Lead sponsor: The Wellcome Sanger Institute
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is looking at two groups of patients having different types of cancer treatment in the study. A research nurse or clinician will highlight a potential participant for recruitment who is under their care and about to receive treatment for cancer. This will usually take place at the multidisciplinary team meeting.

Brief summary: 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.

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

Primary outcomes:
measure: To measure the frequency of acquired (somatic) mutations
timeFrame: 5 years
measure: To measure the size of acquired (somatic) mutations
timeFrame: 5 years
Secondary outcomes:
measure: To understand the nature of acquired (somatic) mutations
timeFrame: 5 years
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Wellcome Sanger Institute
Study officials:
affiliation: Wellcome Sanger Institute
name: Phil Jones
role: PRINCIPAL_INVESTIGATOR
References: