Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT05623956
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2022-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proteomics in Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification and validation of protein biomarkers', 'timeFrame': '3 years', 'description': 'For identification and validation of protein biomarkers both untargeted and targeted proteomics will be performed, including a discovery-based bottom-up mass spectrometry approach and label-free Quantification Nano Liquid Chromatography Tandem Mass Spectrometry (LFQ nLC-MS/MS), enzyme-linked immunosorbent assay (ELISA)-based proteomics, and Western Blot analyses.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proteomics', 'Biomarkers'], 'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to gather insight into tumor-derived circulating extracellular vesicles-proteins in patients with newly diagnosed small cell lung cancer.', 'detailedDescription': 'The study will include 50 patients with newly diagnosed SCLC, referred to systemic antineoplastic treatment at the Dept. of Oncology, Aalborg University Hospital and blood samples from 50 healthy blood donors.\n\nThe blood samples from SCLC patients will be collected before chemotherapy with Carboplatin and Etoposide and after 2 cycles of chemotherapy.\n\nImaging will be performed at the Dept. of Radiology, Aalborg University Hospital before chemotherapy and after 3 cycles of the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include 50 patients with newly diagnosed SCLC, referred to systemic antineoplastic treatment at the Dept. of Oncology, Aalborg University Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written and signed informed consent\n* Histopathologically and/or cytologically newly-diagnosed SCLC\n* Measurable disease on CT scans\n* Eligibility to receive standard chemotherapy consisting of carboplatin and etoposide\n\nExclusion Criteria:\n\n* Active biopsy-verified second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ\n* Prior treatment for any malignant diseases other than non-melanoma skin cancer and cervical carcinoma in situ\n* Concomitant anticoagulation treatment (acetylsalicylic acid and clopidogrel are allowed)\n* Treatment with any other investigational agent'}, 'identificationModule': {'nctId': 'NCT05623956', 'acronym': 'SCLC-OMICS', 'briefTitle': 'Proteomics in Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Circulating Metabolites and Tumor-derived Extravesicular Proteins in Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'N-20220023'}}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'Region North Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Weronika Maria Szejniuk, MD, PhD', 'role': 'CONTACT', 'email': 'wms@rn.dk', 'phone': '97661524'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'centralContacts': [{'name': 'Borgen Dalsgaard', 'role': 'CONTACT', 'email': 'anbd@rn.dk', 'phone': '97606989'}], 'overallOfficials': [{'name': 'Weronika Szejniuk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Weronika Maria Szejniuk', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}