Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-27 @ 8:18 AM
Study NCT ID:
NCT05902559
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2023-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Novel Biomarkers in Participants Undergoing Targeted Lung Health Checks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2023-06-05', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify novel molecular, immune and clinical biomarkers to improve the sensitivity and specificity of lung cancer screening beyond what is achieved with conventional risk prediction models and low-dose CT scanning.', 'timeFrame': '5 years', 'description': 'This includes proteomics, metabolomics, genomics and immune repertoire characterization performed on peripheral bloods.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Low-dose CT (LDCT) screening for lung cancer (LCS) has been shown to reduce lung cancer specific mortality in multiple randomised controlled trials. However, although LDCT screening has been demonstrated to reduce cancer- specific mortality, there remain outstanding questions regarding how screening can be implemented. In particular, indeterminate nodules are common, and can be challenging to distinguish from benign nodules on CT appearances alone. Furthermore, distinguishing cancers which are likely to become clinically significant from those that will remain indolent is challenging, but essential to prevent over-treatment and overdiagnosis. There is significant interest in using a multi-modal approach to LCS, incorporating biomarkers obtained from minimally-invasive samples alongside LDCT to improve ability to recognise clinically-significant lung cancers at an early stage.\n\nThe Targeted Lung Health Check (TLHC) programme is an NHS programme with the aim of using LDCT screening in appropriately high-risk individuals to improve early diagnosis and survival in lung cancer. The North Central London TLHC programme started in December 2022.\n\nThe purpose of the ALPINE study is to develop a platform to allow collection of minimally-invasive samples from participants undergoing screening within the North Central London TLHC programme. The use of such biomarkers in the diagnosis of lung cancer is a rapidly developing field and novel techniques and technologies are continuously under development. The ALPINE study will generate a cohort with matched biosamples, CT scans and clinical data which will be uniquely well placed to serve to develop or validate biomarkers in lung cancer screening and risk prediction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants eligible for Low Dose CT scan screening in the North Central London Targeted Lung Health Check programme', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attended one of more visits as part of the NCL NHS TLHC programme\n* Adults aged between 55 years and 74 years and 364 days\n* Have capacity and can provide written consent\n\nExclusion Criteria:\n\n* Declines participation in ALPINE\n* Lacking capacity and unable to provide written consent\n* Patients who are considered by the clinician to be unfit/not suitable for enrolment in ALPINE'}, 'identificationModule': {'nctId': 'NCT05902559', 'acronym': 'ALPINE', 'briefTitle': 'Assessment of Novel Biomarkers in Participants Undergoing Targeted Lung Health Checks', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Assessment of Novel Biomarkers in Participants Undergoing Targeted Lung Health Checks', 'orgStudyIdInfo': {'id': '155581'}}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Chuen Ryan Khaw', 'role': 'CONTACT', 'email': 'c.khaw@ucl.ac.uk', 'phone': '02034479005'}, {'name': 'Amyn Bhamani', 'role': 'CONTACT', 'email': 'a.bhamani@ucl.ac.uk'}, {'name': 'Samuel Janes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University College London Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}