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

NCT06832150 | Enrolling By Invitation

• 1 other identifier: 341204
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Somatic Mutation; Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• To understand the nature of acquired (somatic) mutations

  5 years

Study Arms (2)

Non melanoma skin cancer

Skin cancer patients receiving Immune checkpoint immunotherapy.

Other: sample collection; Other: Discussing study; Other: Seeking consent

Head and Neck Cancer

Head and Neck cancer patients receiving chemoradiotherapy.

Other: sample collection; Other: Discussing study; Other: Seeking consent

Interventions

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.

Head and Neck Cancer; Non melanoma skin cancer

Discussing study OTHER

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

Head and Neck Cancer; Non melanoma skin cancer

Seeking consent OTHER

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

Head and Neck Cancer; Non melanoma skin cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Any participant who is known to have Hep B, Hep C or HIV

Sponsors & Collaborators

• The Wellcome Sanger Institute: lead

Study Sites (1)

Wellcome Sanger Institute

Cambridge, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, urine samples and cheek swabs

MeSH Terms

Conditions

Neoplasms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Phil Jones

  Wellcome Sanger Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 18, 2025
• Study Start: November 26, 2024
• Primary Completion (Estimated): May 14, 2028
• Study Completion (Estimated): May 13, 2029
• Last Updated: February 18, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)