Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-04-22 @ 1:04 AM
Study NCT ID:
NCT02653859
Status:
UNKNOWN
Last Update Posted:
2016-01-12
First Post:
2016-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells in Benign and Malignant Lung Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003074', 'term': 'Solitary Pulmonary Nodule'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'lastUpdateSubmitDate': '2016-01-10', 'studyFirstSubmitDate': '2016-01-03', 'studyFirstSubmitQcDate': '2016-01-10', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of circulating tumor cells will be detected in baseline by Immunomagnetic negative screening and targeted polymerase chain reaction(PCR) method.', 'timeFrame': '1 months', 'description': 'The 3 mL of blood will be taked with each patient for CTCs detection.'}], 'secondaryOutcomes': [{'measure': 'The concentration of the tumor marker of pro gastrin releasing peptide(Pro-GRP) will be detected in baseline by Electrochemical luminescence.', 'timeFrame': '1 months', 'description': 'The 2 mL of serum will be extracted.'}, {'measure': 'The concentration of the tumor marker of neurone specific enolase(NSE) will be detected in baseline by Electrochemical luminescence.', 'timeFrame': '1 months', 'description': 'The 2 mL of serum will be extracted.'}, {'measure': 'The concentration of the tumor marker of carcinoembryonic antigen(CEA) will be detected in baseline by Electrochemical luminescence.', 'timeFrame': '1 months', 'description': 'The 2 mL of serum will be extracted.'}, {'measure': 'The concentration of the tumor marker of cytokeratin 19 fragments(CYFRA211) will be detected in baseline by Electrochemical luminescence.', 'timeFrame': '1 months', 'description': 'The 2 mL of serum will be extracted.'}, {'measure': 'The concentration of the tumor marker of squamous cell carcinoma antigen(SCC) will be detected in baseline by Electrochemical luminescence.', 'timeFrame': '1 months', 'description': 'The 2 mL of serum will be extracted.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CTC', 'PCR'], 'conditions': ['Solitary Pulmonary Nodule']}, 'descriptionModule': {'briefSummary': 'By testing the CTC number of new solitary pulmonary nodule patient, evaluating the correlation of CTC number and benign and malignant lung nodules auxiliary diagnosis, the correlation of CTC number and the size of lung nodules of the malignant patients, the correlation between the CTC number and subtypes of malignant lung nodules patients.The CTC and tumor markers will be detected before the patient received treatment. Tumor markers include Pro-GRP, NSE, CEA, CYFRA211, SCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'New Solitary Pulmonary Nodule', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New Solitary Pulmonary Nodule patients\n* first visit patient\n* Heart, liver and kidney function is normal.\n* 18-80 years old.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Blood collection time is not in the scheduled time.\n* The plasma sample hemolysis or condensation.\n* Whole blood samples less than 3 ml.\n* poor compliance'}, 'identificationModule': {'nctId': 'NCT02653859', 'briefTitle': 'Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells in Benign and Malignant Lung Nodules', 'organization': {'class': 'INDUSTRY', 'fullName': 'GenoSaber'}, 'officialTitle': 'Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells(CTC) in Benign and Malignant Lung Nodules', 'orgStudyIdInfo': {'id': 'CTC2015-02'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GenoSaber', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}