Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT01963533
Status:
UNKNOWN
Last Update Posted:
2013-10-18
First Post:
2013-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis
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_WITH_DNA', 'description': 'peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-16', 'studyFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2013-10-13', 'lastUpdatePostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between telomere length shortening and cancer treatment outcome', 'timeFrame': '5 years', 'description': "The clinical data, including age, gender, clinical presentation, performance status, disease stage at diagnosis, initial treatment modality, progression-free survival of initial treatment, and survival duration will be recorded. Blood sample collection, quality of life, and cognitive function assessment will be performed before chemotherapy, one and four weeks after initial chemotherapy for telomere length measurement. Telomere length is measured by quantitative polymerase chain reaction(qPCR). Patients' characteristics are compared with chi-square test. Progression-free survival and survival time are analyzed by Kaplan-Meier with log rank test."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung cancer', 'telomere length', 'comorbidity', 'Eastern Cooperation Oncology Group (ECOG)', 'chemotherapy'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.', 'detailedDescription': 'Except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, UV, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as Ha-Ras. The cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. Oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy in National Taiwan University Hospital will be enrolled for screening. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy.\n2. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.\n\nExclusion criteria:\n\nincludes clinical diagnosis of lung cancer without pathology or cytology proving, combined with other type malignancy, and expected short survival time less than one month.'}, 'identificationModule': {'nctId': 'NCT01963533', 'briefTitle': 'The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis', 'orgStudyIdInfo': {'id': '201207006RIC'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuan-Yu Chen, PHD', 'role': 'CONTACT', 'email': 'tuff.chen@msa.hinet.net', 'phone': '886-972651046'}, {'name': 'Chien-Tai Hsu', 'role': 'CONTACT', 'email': 'chiyohsu@yahoo.com.tw', 'phone': '886-223123456', 'phoneExt': '67779'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chia-Lin Hsu', 'role': 'CONTACT', 'email': 'clhsu7@ntu.edu.tw', 'phone': '886-972651890'}, {'name': 'Chien-Tai Hsu', 'role': 'CONTACT', 'email': 'chiyohsu@yahoo.com.tw', 'phone': '886-2-23123456', 'phoneExt': '67779'}], 'overallOfficials': [{'name': 'Kuan-Yu Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NTUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}