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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06832150
Acronym
SMS2
Enrollment
60
Registered
2025-02-18
Start date
2024-11-26
Completion date
2029-05-13
Last updated
2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Somatic Mutation

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.

Interventions

OTHERsample collection

Participants may collected their own cheek swabs and will collect their own urine samples. Clinical professionals at participating sites will collect blood samples.

OTHERDiscussing study

Research Nurse/ Suitably qualified Research Site Staff will discuss the study with potential participants

Potential participants who wish to give consent will do with a Research Nurse/ Suitably qualified Research Site Staff.

Sponsors

The Wellcome Sanger Institute
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To measure the size of acquired (somatic) mutations5 yearsThe study will measure the size of acquired (somatic) mutations in clusters of cells in normal blood, urinary tract and oral cells changes after cancer treatment.
To measure the frequency of acquired (somatic) mutations5 yearsThe study will measure the frequency, size and nature of acquired (somatic) mutations in clusters of cells in normal blood, urinary tract and oral cells changes after cancer treatment.

Secondary

MeasureTime frameDescription
To understand the nature of acquired (somatic) mutations5 yearsThe study will attempt to define and/or understand the behaviour/ nature of acquired (somatic) mutations in clusters of cells in normal blood, urinary tract and oral cells changes after cancer treatment.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026