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

NCT ID: NCT06832150

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-26

Study Completion Date

2029-05-13

Brief Summary

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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

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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

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Somatic Mutation Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Non melanoma skin cancer

Skin cancer patients receiving Immune checkpoint immunotherapy.

sample collection

Intervention Type 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

Intervention Type OTHER

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

Seeking consent

Intervention Type OTHER

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.

sample collection

Intervention Type 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

Intervention Type OTHER

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

Seeking consent

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Discussing study

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

Intervention Type OTHER

Seeking consent

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

Intervention Type OTHER

Eligibility Criteria

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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

* Any participant who is known to have Hep B, Hep C or HIV
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Wellcome Sanger Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Phil Jones

Role: PRINCIPAL_INVESTIGATOR

Wellcome Sanger Institute

Locations

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Wellcome Sanger Institute

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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341204

Identifier Type: -

Identifier Source: org_study_id

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