Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT05742204
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2023-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer
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': 3700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2032-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma proteomic biomarkers', 'timeFrame': '1 month after surgery', 'description': 'Plasma proteomic biomarkers for detection of lung cancer'}, {'measure': 'Model or classifier performance', 'timeFrame': '1 month after surgery', 'description': 'Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer; and model or classifier performance including AUC, sensitivity, specificity, and accuracy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'We will identify plasma proteomics biomarkers for early diagnosis of lung cancer.', 'detailedDescription': 'We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients and controls. Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study group: Patients with suspected or confirmed diagnosis of lung cancer. Control group: Non-cancer subjects including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CT screening results showed that the size of pulmonary nodules was more than 5mm\n* No treatment related to pulmonary nodules/lung cancer (including surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.)\n* Complete clinical and imaging data\n* Chest CT/ low-dose spiral CT reports can be provided in the last 3 months\n* Voluntarily sign informed consent\n\nExclusion Criteria:\n\n* There is a history of tumor\n* Clinically uncontrolled active infections, such as acute pneumonia, tuberculosis, etc.\n* Received any treatment related to pulmonary nodules, such as antibiotics and hormones, in the past 4 weeks\n* Complicated with other tumors and serious diseases of the heart, liver, kidney, brain, blood and other systems\n* Participated in other clinical trials within the last 3 months\n* Combined with liver and kidney insufficiency, hypoproteinemia and other diseases affecting protein content\n* You are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT05742204', 'briefTitle': 'Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Identification and Functional Verification Study in Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer', 'orgStudyIdInfo': {'id': '2022-1109'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung cancer group', 'description': 'Patients age over 18, with confirmed diagnosis of lung cancer.', 'interventionNames': ['Other: Plasma protein biomarker analysis']}, {'label': 'Control group', 'description': 'Non-cancer patients including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.', 'interventionNames': ['Other: Plasma protein biomarker analysis']}], 'interventions': [{'name': 'Plasma protein biomarker analysis', 'type': 'OTHER', 'description': 'Plasma samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment.We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients .', 'armGroupLabels': ['Lung cancer group']}, {'name': 'Plasma protein biomarker analysis', 'type': 'OTHER', 'description': 'Plasma samples of control subjects were collected.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'China', 'country': 'China', 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Weilin Wang', 'role': 'STUDY_CHAIR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}