Somatic MutationSMS2NCT06832150
SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues
An observational study of Somatic Mutation and Cancer, run by The Wellcome Sanger Institute at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Somatic Mutation, Cancer
- What is being tested?
- sample collection, Discussing study and Seeking consent
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2024to 13 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Somatic Mutation, Cancer
- Being tested
- sample collection, Discussing study, Seeking consent
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample collectionOther
Participants may collected their own cheek swabs and will collect their own urine samples.
Clinical professionals at participating sites will collect blood samples.
Discussing studyOther
Research Nurse/ Suitably qualified Research Site Staff will discuss the study with potential participants
Seeking consentOther
Potential participants who wish to give consent will do with a Research Nurse/ Suitably qualified Research Site Staff.
| Study group | Role | What they receive |
|---|---|---|
| Non melanoma skin cancer | Skin cancer patients receiving Immune checkpoint immunotherapy. Receives: Other: sample collection; Other: Discussing study; Other: Seeking consent | |
| Head and Neck Cancer | Head and Neck cancer patients receiving chemoradiotherapy. Receives: Other: sample collection; Other: Discussing study; Other: Seeking consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start26 Nov 2024
- Primary completion14 May 2028 (estimated)
- Study completion13 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Wellcome Sanger Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phil Jones, Principal investigator, Wellcome Sanger Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832150
- Sponsor's protocol ID
- 341204
- Acronym
- SMS2
- Status last verified
- Jul 2024
- First submitted
- 5 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues
- ClinicalTrials.gov ID
- NCT06832150
- Acronym / sponsor ID
- SMS2 / 341204
- Conditions
- Somatic Mutation, Cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Wellcome Sanger InstituteUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 14 May 2028 (estimated)
- Study completion
- 13 May 2029 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non melanoma skin cancer | – | Other: sample collection, Other: Discussing study, Other: Seeking consentSkin cancer patients receiving Immune checkpoint immunotherapy. |
| Head and Neck Cancer | – | Other: sample collection, Other: Discussing study, Other: Seeking consentHead and Neck cancer patients receiving chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sample collectionParticipants may collected their own cheek swabs and will collect their own urine samples. Clinical professionals at participating sites will collect blood samples. | Other | Head and Neck Cancer, Non melanoma skin cancer |
| Discussing studyResearch Nurse/ Suitably qualified Research Site Staff will discuss the study with potential participants | Other | Head and Neck Cancer, Non melanoma skin cancer |
| Seeking consentPotential participants who wish to give consent will do with a Research Nurse/ Suitably qualified Research Site Staff. | Other | Head and Neck Cancer, Non melanoma skin cancer |
Primary outcome
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.
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.
1 secondary outcome
To understand the nature of acquired (somatic) mutations
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phil Jones principal investigator
Wellcome Sanger Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Somatic Mutation and Cancer, run by The Wellcome Sanger Institute at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the frequency of acquired (somatic) mutations (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.