Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT05304494
Status:
WITHDRAWN
Last Update Posted:
2022-05-13
First Post:
2022-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Limited resources', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician assessed severity of breathlessness', 'timeFrame': '1 day (One-time assessment during a participant reported episode of breathlessness)', 'description': 'Breathlessness requiring admission or supplementary oxygen, breathlessness requiring intervention \\< 24 hours, Breathlessness requiring medical intervention within 24 hours without meeting the criteria for severe breathlessness, Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breathlessness', 'COPD', 'Asthma', 'Asthma Chronic', 'Wheezing', 'Dyspnea', 'Shortness of Breath'], 'conditions': ['Breathlessness', 'COPD', 'Asthma', 'Asthma Chronic', 'Wheezing', 'Dyspnea', 'Shortness of Breath']}, 'referencesModule': {'references': [{'pmid': '27603500', 'type': 'BACKGROUND', 'citation': 'Smith AK, Currow DC, Abernethy AP, Johnson MJ, Miao Y, Boscardin WJ, Ritchie CS. Prevalence and Outcomes of Breathlessness in Older Adults: A National Population Study. J Am Geriatr Soc. 2016 Oct;64(10):2035-2041. doi: 10.1111/jgs.14313. Epub 2016 Sep 7.'}, {'pmid': '32539537', 'type': 'BACKGROUND', 'citation': 'Tobin MJ, Laghi F, Jubran A. Why COVID-19 Silent Hypoxemia Is Baffling to Physicians. Am J Respir Crit Care Med. 2020 Aug 1;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.'}, {'pmid': '23971625', 'type': 'BACKGROUND', 'citation': 'Barnes N, Calverley PM, Kaplan A, Rabe KF. Chronic obstructive pulmonary disease and exacerbations: patient insights from the global Hidden Depths of COPD survey. BMC Pulm Med. 2013 Aug 23;13:54. doi: 10.1186/1471-2466-13-54.'}, {'pmid': '27354781', 'type': 'BACKGROUND', 'citation': 'Coutinho AD, Lokhandwala T, Boggs RL, Dalal AA, Landsman-Blumberg PB, Priest J, Stempel DA. Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population. Int J Chron Obstruct Pulmon Dis. 2016 Jun 8;11:1223-31. doi: 10.2147/COPD.S102570. eCollection 2016.'}, {'pmid': '12513067', 'type': 'BACKGROUND', 'citation': 'Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG; Standards for Reporting of Diagnostic Accuracy. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med. 2003 Jan 7;138(1):W1-12. doi: 10.7326/0003-4819-138-1-200301070-00012-w1.'}], 'seeAlsoLinks': [{'url': 'http://www.hra-decisiontools.org.uk/research/', 'label': 'Health Research Authority. Is my study research?'}, {'url': 'https://s3.eu-west-2.amazonaws.com/www.hra.nhs.uk/media/documents/hra-mhra-econsent-statement-sept-18.pdf', 'label': 'MHRA, Health and care research Wales, NHS Scotland, Health and Social Care \\& NHS Health Research Authority. Joint statement on seeking consent by electronic methods'}]}, 'descriptionModule': {'briefSummary': 'The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants having experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-90 years.\n* Has experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional. Self-reported breathlessness using any of the following words to describe symptoms will qualify as a presentation of breathlessness regardless of aetiology or severity of symptoms: shortness of breath, tight chest, trouble breathing, breathlessness, dyspnoeic, breathless, asthmatic, suffocating, wheezing, fighting for breath or any equivalent word. Breathlessness does not have to be the primary presenting symptom.\n* Deemed clinically sufficiently stable to participate according to health care practitioner.\n\nExclusion Criteria:\n\n* Inability to understand written local language at a year 5 level.\n* Not being confident in use of digital technology (smartphone and/or tablet). This will become evident through an inability to use the system.\n* Inability to enter required study sample data due to diminished consciousness and/or physical or mental capacity regardless of whether this is associated with the breathlessness event.\n* Received an investigational medical product in the context of a Clinical Trial during the 28 days prior to first probe administration.'}, 'identificationModule': {'nctId': 'NCT05304494', 'briefTitle': 'Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanome'}, 'officialTitle': 'Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers', 'orgStudyIdInfo': {'id': 'Sentinel - 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe Breathlessness', 'description': 'Breathlessness requiring admission or supplementary oxygen', 'interventionNames': ['Other: Biomarker tests for participant profiling']}, {'label': 'Moderate Breathlessness', 'description': 'Breathlessness requiring medical intervention \\< 24 hours without meeting the criteria for severe breathlessness', 'interventionNames': ['Other: Biomarker tests for participant profiling']}, {'label': 'Mild Breathlessness', 'description': 'Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan', 'interventionNames': ['Other: Biomarker tests for participant profiling']}], 'interventions': [{'name': 'Biomarker tests for participant profiling', 'type': 'OTHER', 'description': 'Combination of digital and physical tests to objectify measures relevant for breathlessness', 'armGroupLabels': ['Mild Breathlessness', 'Moderate Breathlessness', 'Severe Breathlessness']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanome', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}