Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06832150

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wellcome Sanger Institute

Cambridge, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample collection

Other

Participants may collected their own cheek swabs and will collect their own urine samples.

Clinical professionals at participating sites will collect blood samples.

Discussing study

Other

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

Seeking consent

Other

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

Primary outcomes

  1. To measure the frequency of acquired (somatic) mutations

    Time frame: 5 years

    The 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.

  2. To measure the size of acquired (somatic) mutations

    Time frame: 5 years

    The 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.

Secondary outcomes

  1. To understand the nature of acquired (somatic) mutations

    Time frame: 5 years

    The 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.

Sponsors and collaborators

Lead sponsor

The Wellcome Sanger Institute

Other

Registry information

Acronym: SMS2

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.