Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04287712
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2020-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Lung Cancer by Plasma Lipids
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'For enrolled participants, 4 ml of peripheral blood were collected in tubes containing EDTA and all participants had fasted at least 8 hr before blood collection. Whole blood was centrifuged at 1600 g for 10 min followed by centrifugation at 16000 g for 10 min. Plasma aliquots were transferred into cryovials and stored at -80 °C.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 558}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2020-02-13', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Lipids', 'timeFrame': 'All samples were detected together after participants recruitment and sample collection. All samples were detected within 18 months from sample collection.', 'description': 'A detection model based on 9 lipids were developed, including 3 lysophosphatidylcholines, 5 phosphatidylcholines, and a triglyceride. The 9 lipids were detected by targeted metabolomics by mass spectrometry.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early-Stage Lung Cancer', 'Plasma Metabolomics', 'Lipids', 'Machine Learning'], 'conditions': ['Early-Stage Lung Cancer']}, 'descriptionModule': {'briefSummary': 'There are no reliable blood-based tests currently available for early-stage lung cancer diagnosis. We try to establish a highly accurate method for detecting early-stage lung cancer by combining machine learning with untargeted and targeted metabolomics .', 'detailedDescription': 'All plasma lipids were first detected by untargeted metabolomics methods and 9 feature lipids of early-stage lung cancer were selected by support vector machine algorithm. Then, a targeted metabolomics method was developed to detect the 9 lipids quantitatively based on multiple reaction monitoring mode. Finally, a detection model was established based on the 9 lipids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients who with pulmonary nodules or opacity and underwent surgery at the Department of Thoracic Surgery of Peaking University People's Hospital, Jiangsu Cancer Hospital, and Beijing Haidian Hospital were enrolled", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pulmonary nodules or opacity\n2. plan to receive surgery\n\nExclusion Criteria:\n\n1. history of other malignancies\n2. received anti-cancer treatment (chemotherapy, radiotherapy, targeted therapy, etc.) before surgery'}, 'identificationModule': {'nctId': 'NCT04287712', 'acronym': 'ELAID', 'briefTitle': 'Detection of Lung Cancer by Plasma Lipids', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Detection of Early-stage Lung Cancer Using Machine Learning and Plasma Metabolomics', 'orgStudyIdInfo': {'id': '2018PHB233-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants received surgery', 'description': "Patients who underwent surgery at the Department of Thoracic Surgery of Peaking University People's Hospital, Jiangsu Cancer Hospital, and Beijing Haidian Hospital were enrolled with the following criteria: 1) pathologically confirmed lung cancer; 2) no history of other malignancies; 3) no anti-cancer treatment (chemotherapy, radiotherapy, targeted therapy, etc.) before surgery. Plasma samples were collected before surgery and plasma lipids were detected by mass spectrometry. Pathological diagnosis and clinical characteristics of enrolled participants were retrieved.", 'interventionNames': ['Diagnostic Test: Plasma lipids']}], 'interventions': [{'name': 'Plasma lipids', 'type': 'DIAGNOSTIC_TEST', 'description': 'Plasma lipids were detected by an Ultimate 3000 ultra-high-performance liquid chromatography (UHPLC) system coupled with Q-Exactive MS (Thermo Scientific) . Then a detection model was built based on plasma lipids using machine learning algorithm.', 'armGroupLabels': ['Participants received surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Haidian Hospital', 'class': 'OTHER'}, {'name': 'Jiangsu Cancer Institute & Hospital', 'class': 'OTHER'}, {'name': 'Peking University Health Science Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Jun Wang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}