Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT06695494
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enabling Genomic Testing in Cancer of Unknown Primary
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009382', 'term': 'Neoplasms, Unknown Primary'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples for genetic analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Development of novel biomarkers to help in the diagnosis and treatment of patients diagnosed with CUP', 'timeFrame': 'Future research sample collection performed at baseline visit. 33 months of recruitment or 1st December 2026 whichever comes first', 'description': 'Collect samples to be used to investigate novel biomarkers to help in the diagnosis and treatment in patients diagnosed with CUP'}], 'primaryOutcomes': [{'measure': 'Evaluate the utility of cfDNA molecular profiling in patients diagnosed with CUP', 'timeFrame': '33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first', 'description': '1. Percentage of patients with adequate cfDNA yields measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints\n2. Percentage of patients with actionable genomic alterations measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints\n3. Percentage of patients eligible for personalised treatment options or enrolment on a UK-based clinical trial because of the cfDNA results, measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints'}], 'secondaryOutcomes': [{'measure': 'Data collection repository of readily available information on trails/treatments for patients diagnosed with CUP', 'timeFrame': '33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first', 'description': 'Develop a data collection repository and readily available information on trials/treatments for patients diagnosed with CUP to be shared at monthly trial management group meetings to ensure that investigators are aware of suitable trial opportunities'}, {'measure': 'Incorporate molecular genomics into routine practice', 'timeFrame': '33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first', 'description': 'Routinely incorporate molecular genomics as standard of care in patients diagnosed with CUP following FoundationOne®️ CDx or FoundationOne®️ Liquid CDx at baseline and FoundationOne®️ Liquid CDx at progression'}, {'measure': 'Document and feedback genomic results to treating team and patients', 'timeFrame': '33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first', 'description': 'Documentation and feedback of genomic results/GTAB outcomes to all patients and treating teams following FoundationOne®️ CDx or FoundationOne®️ Liquid CDx at baseline, and FoundationOne®️ Liquid CDx at progression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer of unknown primary', 'Cancer'], 'conditions': ['Cancer of Unknown Primary', 'Neoplasm, Unknown Primary']}, 'descriptionModule': {'briefSummary': 'Cancer of Unknown Primary (CUP) is where cancer cells are found in the body but the place the cancer began is not known. It is the 6th leading cause of cancer death in the UK and the prognosis is poor with a median survival of 6-9 months. There is a higher than average incidence of CUP in the North West (NW) of England (population of 7.4 million). Precision medicine has transformed treatment strategies in known tumour types, however in CUP there remains an urgent need to better understand CUP molecular characteristics to establish potential roles for novel therapeutic strategies. Treatment options remain limited due to difficulties in determining the primary site of the tumour and the lack of access to validated biomarkers. Access to good-quality tissue for molecular profiling remains a huge challenge in CUP. The emergence of liquid biopsies (sequence DNA in a blood test) as a source of biomarkers is also gaining rapid ground and this study aims to explore the potential utility of liquid biopsies in CUP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with cancer of unknown primary', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged 16 years or over\n2. Written informed consent according to ICH/GCP and national regulations\n3. ECOG Performance status 0-2\n4. Confirmed diagnosis of CUP as per the ESMO guidelines. Patients must have;\n\n 1. The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis\n 2. Discussion at a local CUP MDT confirming diagnosis\n5. Availability of archival tumour histological report\n6. Willingness to provide blood samples on up to two occasions during the study\n\nExclusion Criteria:\n\n1. Patient with an immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment\n2. Known HIV, Hepatitis B, C positive, due to the difficulties in handling high-risk specimens\n3. Patients who are unable to provide fully informed written consent\n4. Presence of any medical, psychological, familial or sociological condition that, in the investigator's opinion, will hamper compliance with the study protocol and follow-up schedule\n5. Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable blood sampling)\n6. Conditions in which blood sampling may increase risk of complications for the patients and/or investigator"}, 'identificationModule': {'nctId': 'NCT06695494', 'acronym': 'EGGCUP', 'briefTitle': 'Enabling Genomic Testing in Cancer of Unknown Primary', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'Enabling Genomic Testing in Cancer of Unknown Primary', 'orgStudyIdInfo': {'id': 'CFTSp213'}, 'secondaryIdInfos': [{'id': 'ISRCTN42910771', 'type': 'REGISTRY', 'domain': 'International Standard Randomised Controlled Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'description': 'Blood sample collection for gene panel array testing and simultaneous research purposes', 'interventionNames': ['Diagnostic Test: Gene panel array', 'Other: Blood Sample Collection']}], 'interventions': [{'name': 'Gene panel array', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood sample collection for gene panel testing', 'armGroupLabels': ['All participants']}, {'name': 'Blood Sample Collection', 'type': 'OTHER', 'description': 'Blood sample collection for research purposes', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'Greater Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Natalie Cook', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Liverpool', 'state': 'Merseyside', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Eliyaz Ahmed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Clatterbridge Cancer Centre NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Blackpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Pavel Bezecny', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Blackpool Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'Manchester', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': "Paul O'Donnell", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northern Care Alliance NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Morecambe', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'N Chan Ton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals of Morecambe Bay NHS Trust', 'geoPoint': {'lat': 54.06835, 'lon': -2.86108}}, {'city': 'Preston', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Catherine Mitchell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lancashire Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}], 'centralContacts': [{'name': 'EGG CUP Study Team', 'role': 'CONTACT', 'email': 'the-christie.egg-cup@nhs.net', 'phone': '+44 161 918 7672'}], 'overallOfficials': [{'name': 'Natalie Cook', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, {'name': 'University of Manchester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}