Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT06820294
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-11
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective WGS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The cost of whole genome sequencing', 'timeFrame': '5.5 years', 'description': 'The cost of whole genome sequencing versus standard of care assays as performed for each patient'}], 'primaryOutcomes': [{'measure': 'The proportion of children clinically benefiting from whole genome sequencing', 'timeFrame': '5.5 years', 'description': 'The proportion of children clinically benefiting from whole genome sequencing in terms of improving diagnoses, treatment, and prognostication, amongst other aspects'}], 'secondaryOutcomes': [{'measure': 'Relation between mutation data and disease phenotypes', 'timeFrame': '5.5 years', 'description': 'To describe possible associations between genetic features and clinical phenotypes. What these associations look like will depend on the study results.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Pediatric Cancer', 'Neoplasm']}, 'descriptionModule': {'briefSummary': 'This retrospective case series reviews clinical notes to assess whether NHS whole genome sequencing provides tangible benefits for paediatric tumours.', 'detailedDescription': 'The NHSE-commissioned whole genome sequencing programme went live at the end of 2020. It remains as yet unproven, whether this whole genome sequencing programme for children with cancer can deliver tangible benefits in real-time. There is an urgent need, therefore, to assess whether children with tumours who are receiving NHS whole genome sequencing are actually benefiting from this additional assay. This is a retrospective case series. The principal methodology is that of reviewing clinical notes to assess whether children with tumours have benefited from NHSE whole genome sequencing. Apart from the contribution of our work to the scientific literature, this research will inform government on the potential benefits, or lack thereof, of the live NHSE whole genome programme and has the potential to influence policy on whether this programme should be continued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All children and young people (up to the age of 21 years) diagnosed with a neoplastic disorder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children and young people (up to the age of 21 years) diagnosed with a neoplastic disorder who have been offered NHSE whole genome sequencing.\n\nExclusion Criteria:\n\n* Anyone not offered NHSE whole genome sequencing\n* Individuals beyond the age of 21\n* Individuals without a neoplastic disorder.'}, 'identificationModule': {'nctId': 'NCT06820294', 'briefTitle': 'Retrospective WGS Study', 'organization': {'class': 'OTHER', 'fullName': 'The Wellcome Sanger Institute'}, 'officialTitle': 'Assessing the Clinical Benefits of Whole Genome Sequencing for Children With Neoplasms', 'orgStudyIdInfo': {'id': '319310'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All children/young people (up to 21years) diagnosed with neoplastic disorder who have had NHSE WGS', 'description': 'All children and young people (up to the age of 21 years) diagnosed with a neoplastic disorder who have been offered NHSE whole genome sequencing.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'As per widely adopted clinical research practice for case reviews of de-identified, anonymised data, no explicit consent of participants (or their legal guardians) would be required for this study other than the consent they provided at biopsy (from which the whole genome sequencing data is derived) for researchers to access their notes (as documented on hospital consent form).', 'armGroupLabels': ['All children/young people (up to 21years) diagnosed with neoplastic disorder who have had NHSE WGS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Wellcome Sanger Institute', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Wellcome Sanger Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}