Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT05811169
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-13
First Post:
2023-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quest for Tumour Evolution of Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059014', 'term': 'High-Throughput Nucleotide Sequencing'}], 'ancestors': [{'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The formalin-fixed paraffin embedded tumour and lymph node samples of non-small cell lung cancer as well as blood, plasma and serum samples are retrieved and collected for next-generation sequencing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2023-02-26', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intratumour heterogeneity', 'timeFrame': '5 years', 'description': 'Number of participants who have single actionable and non-actionable genetic mutations and multiple actionable and non-actionable genetic mutations within the same groups of patients with early and metastatic non-small cell lung cancer'}, {'measure': 'Intertumour heterogeneity', 'timeFrame': '5 years', 'description': 'Number of participants who have single actionable and non-actionable genetic mutations and multiple actionable and non-actionable genetic mutations of different groups of patients with early and metastatic non-small cell lung cancer'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Next Generation Sequencing'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To study and comprehend the evolutionary and genomic landscape between primary and metastatic sites and the dynamics of intratumour and intertumour heterogeneity over time with reference to the treatment modalities for each Chinese patient with non-small cell lung cancer.', 'detailedDescription': 'The importance of intratumour and intertumour heterogeneity in non-small cell lung cancer has been extensively interrogated recently. However there is a lack of similar data associated with treatment and survival outcomes in Chinese population. Unicorn-Quest, a prospective observational study of Chinese patients with either primary or metastatic non-small cell lung cancer, aims to identify the evolutionary changes from the primary tumour, regional nodes and distant metastases of the same patients and among different patients, through multiregion and longitudinal tumour and nodal collection with next-generation sequencing. By following non-small cell lung cancer from early stage to relapse or distant metastasis, identifying the changes of genomic landscape with correlation with treatment and survival outcomes, this study may help identify unique cancer trajectories and novel therapeutic targets for non-small cell lung cancer in Chinese population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stage I to IVB non-squamous non-small cell lung cancer', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written Informed consent\n* Patients ≥18 years of age, with histologically confirmed non-squamous non-small cell lung cancer who plan to receive active anti-cancer treatment for their non-small cell lung cancer.\n* Sufficient tissues with a minimum of two tumour or nodal regions are available for the study based on pre-operative imaging and post-operative pathological findings.\n\nExclusion Criteria:\n\n* Any other\\* malignancy diagnosed or relapsed at any time, which is currently being treated (including by hormonal therapy).\n\nAny other\\* current malignancy or malignancy diagnosed or relapsed within the past 3 years\\*\\*.\n\n\\*Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer\n\n\\*\\*An exception will be made for malignancies diagnosed or relapsed more than 2, but less than 3, years ago only if a pre-operative biopsy of the lung lesion has confirmed a diagnosis of NSCLC.\n\n* Psychological condition that would preclude informed consent'}, 'identificationModule': {'nctId': 'NCT05811169', 'briefTitle': 'Quest for Tumour Evolution of Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Quest for Tumour Evolution of Non-small Cell Lung Cancer in Chinese (Unicorn-Quest)', 'orgStudyIdInfo': {'id': 'UW 20-145'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early or metastatic non-small cell lung cancer', 'description': 'The formalin-fixed paraffin-embedded specimen will be retrieved for next generation sequencing.', 'interventionNames': ['Genetic: Next generation sequencing']}], 'interventions': [{'name': 'Next generation sequencing', 'type': 'GENETIC', 'description': 'Next generation sequencing', 'armGroupLabels': ['Early or metastatic non-small cell lung cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Clinical Oncology, Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Victor Ho-Fun Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Mary Hospital, Hong Kong', 'class': 'OTHER'}, {'name': 'Queen Elizabeth Hospital, Hong Kong', 'class': 'OTHER'}, {'name': 'Pamela Youde Nethersole Eastern Hospital', 'class': 'OTHER'}, {'name': 'Prince of Wales Hospital, Shatin, Hong Kong', 'class': 'OTHER'}, {'name': 'Princess Margaret Hospital, Hong Kong', 'class': 'OTHER_GOV'}, {'name': 'Tuen Mun Hospital', 'class': 'OTHER_GOV'}, {'name': 'United Christian Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}