Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-28 @ 11:16 AM
Study NCT ID:
NCT06864195
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy of VOC Analysis for Liver Cancer Detection', 'timeFrame': 'Day 1', 'description': 'This outcome measures the ability of volatile organic compound (VOC) analysis in exhaled breath to accurately detect liver cancer. Breath samples will be analysed using thermal desorption gas chromatography-mass spectrometry (TD-GC-MS). The diagnostic accuracy will be determined by comparing VOC profiles with histological confirmation or radiological imaging as the reference standard. Sensitivity, specificity, and area under the receiver operating characteristic curve (AU-ROC) will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breath', 'liver cancer', 'cirrhosis'], 'conditions': ['Liver Cirrhosis', 'Hepatocellular Carcinoma (HCC)', 'Cholangiocarcinoma', 'Cholangitis, Sclerosing']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.wcrf.org/cancer-trends/liver-cancer-statistics/', 'label': 'Related Info'}, {'url': 'https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/liver-cancer', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Liver cancer is often diagnosed too late for effective treatment. The VOCAL2 study is developing a simple, non-invasive breath test to help detect liver cancer earlier and monitor liver conditions like cirrhosis. The test analyzes tiny chemicals in exhaled breath called volatile organic compounds (VOCs) to identify signs of liver disease.\n\nWho can take part?\n\nAdults aged 18 or older who:\n\nHave liver cancer (hepatocellular carcinoma or cholangiocarcinoma), or Have liver cirrhosis or primary sclerosing cholangitis, or Have tummy symptoms but a normal liver scan. What's involved?\n\nParticipants will:\n\nGive a breath sample after fasting for 6 hours. Answer a few health questions. Allow access to relevant medical records. The appointment lasts about 1 hour at an NHS hospital. Benefits \\& Risks\n\nThis research could lead to an earlier, easier way to detect liver cancer, but there's no direct health benefit for participants.\n\nThere are no risks, as breath sampling is completely non-invasive and safe. Where is the study happening? Led by Imperial College London, running in NHS hospitals across the UK.\n\nWho is funding the study? The study is funded by Rosetrees and Stoneygate Trust.\n\nContact Information Email: vocal-study@imperial.ac.uk Phone: +44 (0)20 7594 3396"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People from secondary or tertiary centers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Adult participants ≥ 18 years old\n* Participants with either:\n\n 1. Histologically or radiologically-confirmed\\* hepatocellular carcinoma or cholangiocarcinoma (participants with liver cancer)\n 2. Liver cirrhosis, confirmed on imaging or histology from biopsy (participants with benign liver disorders)\n 3. Primary sclerosing cholangitis, confirmed on MRCP/ERCP or histology from biopsy (participants with benign liver disorders)\n 4. Non-specific gastrointestinal symptoms, but a radiologically-normal liver (healthy controls)\n\nExclusion Criteria:\n\n* Active infection, or receiving immunosuppressive medications, within the preceding eight weeks\n* History of another cancer within the previous five years\n* Previous liver resection\n* Already received chemotherapy, radiotherapy or surgery for their liver cancer\n* Comorbidities preventing breath collection\n* Pregnant women (checked verbally with participant).\n* Unable to provide informed written consent'}, 'identificationModule': {'nctId': 'NCT06864195', 'acronym': 'VOCAL2', 'briefTitle': 'A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Development of a Breath Test Using Volatile Organic Markers for Monitoring Cirrhosis and Detecting Primary Liver Tumours (VOCAL2)', 'orgStudyIdInfo': {'id': '175288'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'participants with liver cancer', 'description': 'Histologically or radiologically-confirmed hepatocellular carcinoma or cholangiocarcinoma'}, {'label': 'participants with benign liver disorders', 'description': '1. Liver cirrhosis, confirmed on imaging or histology from biopsy or\n2. Primary sclerosing cholangitis, confirmed on MRCP/ERCP or histology from biopsy'}, {'label': 'healthy controls', 'description': 'Non-specific gastrointestinal symptoms, but a radiologically-normal liver'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Georgios Karagiannidis', 'role': 'CONTACT', 'email': 'vocal-study@imperial.ac.uk', 'phone': '+02075943396'}], 'facility': 'Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Georgios Karagiannidis, MBBS(Hon)', 'role': 'CONTACT', 'email': 'vocal-study@imperial.ac.uk', 'phone': '+02075943396'}], 'overallOfficials': [{'name': 'George Hanna', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}