SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues (SMS2)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cancer; Somatic Mutation
• Intervention / Treatment: Other: sample collection; Other: Discussing study; Other: Seeking consent

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom
    • Wellcome Sanger Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non melanoma skin cancer; Skin cancer patients receiving Immune checkpoint immunotherapy.	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.
Head and Neck Cancer; Head and Neck cancer patients receiving chemoradiotherapy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the frequency of acquired (somatic) mutations	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.	5 years
To measure the size of acquired (somatic) mutations	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To understand the nature of acquired (somatic) mutations	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.	5 years

Collaborators and Investigators

• Sponsor: The Wellcome Sanger Institute
• Investigators: Principal Investigator: Phil Jones, Wellcome Sanger Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Estimated): May 14, 2028
• Study Completion (Estimated): May 13, 2029

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 341204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No