Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
Study NCT ID:
NCT06832150
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-18
First Post:
2025-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples, urine samples and cheek swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-05-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure the frequency of acquired (somatic) mutations', 'timeFrame': '5 years', 'description': '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.'}, {'measure': 'To measure the size of acquired (somatic) mutations', 'timeFrame': '5 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'To understand the nature of acquired (somatic) mutations', 'timeFrame': '5 years', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Somatic Mutation', 'Cancer']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female\n* Due to commence systemic treatment for histologically confirmed cancer at a - participating site\n* Age over 18 years\n* Able to give informed consent.\n* Able to give urine, blood and cheek swab samples on two occasions.\n* Likely to complete 3 months of treatment\n\nExclusion Criteria:\n\n* 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.\n* Any participant who is known to have Hep B, Hep C or HIV'}, 'identificationModule': {'nctId': 'NCT06832150', 'acronym': 'SMS2', 'briefTitle': 'SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues', 'organization': {'class': 'OTHER', 'fullName': 'The Wellcome Sanger Institute'}, 'officialTitle': 'SMS 2: Impact of Cancer Therapy on the Somatic Mutational Landscape of Normal Tissues', 'orgStudyIdInfo': {'id': '341204'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non melanoma skin cancer', 'description': 'Skin cancer patients receiving Immune checkpoint immunotherapy.', 'interventionNames': ['Other: sample collection', 'Other: Discussing study', 'Other: Seeking consent']}, {'label': 'Head and Neck Cancer', 'description': 'Head and Neck cancer patients receiving chemoradiotherapy.', 'interventionNames': ['Other: sample collection', 'Other: Discussing study', 'Other: Seeking consent']}], 'interventions': [{'name': 'sample collection', 'type': 'OTHER', 'description': 'Participants may collected their own cheek swabs and will collect their own urine samples.\n\nClinical professionals at participating sites will collect blood samples.', 'armGroupLabels': ['Head and Neck Cancer', 'Non melanoma skin cancer']}, {'name': 'Discussing study', 'type': 'OTHER', 'description': 'Research Nurse/ Suitably qualified Research Site Staff will discuss the study with potential participants', 'armGroupLabels': ['Head and Neck Cancer', 'Non melanoma skin cancer']}, {'name': 'Seeking consent', 'type': 'OTHER', 'description': 'Potential participants who wish to give consent will do with a Research Nurse/ Suitably qualified Research Site Staff.', 'armGroupLabels': ['Head and Neck Cancer', 'Non melanoma skin cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Wellcome Sanger Institute', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Phil Jones', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wellcome Sanger Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Wellcome Sanger Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}