Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-01 @ 6:12 AM
Study NCT ID:
NCT02437760
Status:
UNKNOWN
Last Update Posted:
2015-05-08
First Post:
2015-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognostic and Predictive Value of the CA-125 Marker in Lung Cancer Monitoring
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2015-04-18', 'studyFirstSubmitQcDate': '2015-05-05', 'lastUpdatePostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic Value of the cancer antigen-125 in lung cancer', 'timeFrame': '12months', 'description': '1. Comparison of CA-125 level in serum between lung cancer patients with or without malignant pleural effusion\n2. The correlation between serum and pleural effusion CA-125 level'}], 'secondaryOutcomes': [{'measure': 'The prognostic value of the cancer antigen-125 in lung cancer', 'timeFrame': '24 months', 'description': '1. Association of serum/ pleural effusion CA-125 level with Disease-Free Survival and Overall Survival\n2. The correlation of CA-125 response at the 3rd , the 6th month between tumor lesion change\n3. Analysis of survival in relation to CA-125 response'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer, including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at advanced stage. Malignant pleural effusion secondary to lung cancer represented the condition of cancer cell involved pleura.\n\nThe CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could be correlated with the prognosis. This study was performed to examine the properties of CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary therapy as a surrogate indicator for survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with histologically proved lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proved lung cancer\n\nExclusion Criteria:\n\n* History of other cancers within the past 5 years\n* Pregnancy or breast milk feeding\n* TB pleuritis and peritonitis'}, 'identificationModule': {'nctId': 'NCT02437760', 'briefTitle': 'The Prognostic and Predictive Value of the CA-125 Marker in Lung Cancer Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'E-DA Hospital'}, 'officialTitle': 'Determination of the Prognostic and Predictive Value of the Cancer Antigen-125 (CA-125) Marker in Lung Cancer Monitoring', 'orgStudyIdInfo': {'id': 'EMRP49103N'}}, 'armsInterventionsModule': {'interventions': [{'name': 'serum and pleural effusion CA-125 level', 'type': 'OTHER', 'description': 'serum and pleural effusion(if exist) CA-125 are collected:\n\n* at time of diagnosis\n* every 3 month during treatment\n* stop at the progression or after 12 months'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jiun-Ting Wu, MD', 'role': 'CONTACT', 'email': 'jt600729@ms13.hinet.net', 'phone': '886-7-615-0011', 'phoneExt': '5026'}, {'name': 'Jiun-Ting Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'E-DA hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Jiun-Ting Wu, MD', 'role': 'CONTACT', 'email': 'ed103621@edah.org.tw', 'phone': '886-07-6150011', 'phoneExt': '5026'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'E-DA Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}