Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2026-02-28 @ 8:18 AM
Study NCT ID:
NCT02907606
Status:
UNKNOWN
Last Update Posted:
2016-09-20
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fresh tumor tissue, peripheral blood samples and urinary samples will be collected from each patient.\n\nTime:Preoperative, intraoperative, 3 days and 1、6、12 months after surgery.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'The difference of urine ctDNA detection effectiveness between different TNM stages NSCLC patients.', 'timeFrame': '18 months'}, {'measure': 'Correlation of urine ctDNA concentration preoperative,intraoperative and 3 days after surgery with clinical features and prognosis.', 'timeFrame': '18 months'}, {'measure': 'Lead time of tumor relapse detection by urine ctDNA than tumor markers and radiographic approaches.', 'timeFrame': '3 years'}, {'measure': 'Urinary ctDNA predictive value for locoregional recurrence and distant metastasis.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-small-cell Lung Cancer', 'circulating tumor DNA', 'urine'], 'conditions': ['Carcinoma', 'Non-small-cell Lung Cancer', 'Lung Neoplasms']}, 'referencesModule': {'references': [{'pmid': '27468937', 'type': 'BACKGROUND', 'citation': 'Reckamp KL, Melnikova VO, Karlovich C, Sequist LV, Camidge DR, Wakelee H, Perol M, Oxnard GR, Kosco K, Croucher P, Samuelsz E, Vibat CR, Guerrero S, Geis J, Berz D, Mann E, Matheny S, Rolfe L, Raponi M, Erlander MG, Gadgeel S. A Highly Sensitive and Quantitative Test Platform for Detection of NSCLC EGFR Mutations in Urine and Plasma. J Thorac Oncol. 2016 Oct;11(10):1690-700. doi: 10.1016/j.jtho.2016.05.035. Epub 2016 Jul 25.'}, {'pmid': '18837947', 'type': 'BACKGROUND', 'citation': 'Su YH, Wang M, Brenner DE, Norton PA, Block TM. Detection of mutated K-ras DNA in urine, plasma, and serum of patients with colorectal carcinoma or adenomatous polyps. Ann N Y Acad Sci. 2008 Aug;1137:197-206. doi: 10.1196/annals.1448.027.'}, {'pmid': '21726666', 'type': 'BACKGROUND', 'citation': 'Lin SY, Dhillon V, Jain S, Chang TT, Hu CT, Lin YJ, Chen SH, Chang KC, Song W, Yu L, Block TM, Su YH. A locked nucleic acid clamp-mediated PCR assay for detection of a p53 codon 249 hotspot mutation in urine. J Mol Diagn. 2011 Sep;13(5):474-84. doi: 10.1016/j.jmoldx.2011.05.005. Epub 2011 Jul 2.'}, {'pmid': '25003820', 'type': 'BACKGROUND', 'citation': 'Janku F, Vibat CR, Kosco K, Holley VR, Cabrilo G, Meric-Bernstam F, Stepanek VM, Lin PP, Leppin L, Hassaine L, Poole JC, Kurzrock R, Erlander MG. BRAF V600E mutations in urine and plasma cell-free DNA from patients with Erdheim-Chester disease. Oncotarget. 2014 Jun 15;5(11):3607-10. doi: 10.18632/oncotarget.1964.'}, {'pmid': '25324352', 'type': 'BACKGROUND', 'citation': 'Hyman DM, Diamond EL, Vibat CR, Hassaine L, Poole JC, Patel M, Holley VR, Cabrilo G, Lu TT, Arcila ME, Chung YR, Rampal R, Lacouture ME, Rosen N, Meric-Bernstam F, Baselga J, Kurzrock R, Erlander MG, Janku F, Abdel-Wahab O. Prospective blinded study of BRAFV600E mutation detection in cell-free DNA of patients with systemic histiocytic disorders. Cancer Discov. 2015 Jan;5(1):64-71. doi: 10.1158/2159-8290.CD-14-0742. Epub 2014 Oct 16.'}, {'pmid': '23836314', 'type': 'BACKGROUND', 'citation': 'Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.', 'detailedDescription': 'Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring.\n\nUrinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine.\n\nThis study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Histologically confirmed stage non-small cell lung cancer patients with paired tumor tissue, peripheral blood samples, and urinary samples.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 80 years\n* Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection\n* Completed and explicit information about TNM staging\n* Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery.\n* Patients must have given written informed consent\n\nExclusion Criteria:\n\n* Unable to comply with the study procedure\n* Malignant tumor history within the past 5 years\n* Coexisting small cell lung cancer\n* Unqualified tissue, blood or urine samples'}, 'identificationModule': {'nctId': 'NCT02907606', 'briefTitle': 'Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study', 'orgStudyIdInfo': {'id': 'PKUPH-XW1401'}}, 'contactsLocationsModule': {'locations': [{'zip': '+86-010', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Xiao Li, M.D', 'role': 'CONTACT', 'email': 'dr.lixiao@163.com', 'phone': '+86-10-88326652'}, {'name': 'Hao Li, M.D', 'role': 'CONTACT', 'email': 'lihao_pkuhsc@163.com', 'phone': '+86-10-88326650', 'phoneExt': 'Li'}, {'name': 'Jun Wang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiao Li, M.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Peking University People'S Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiao Li, M.D', 'role': 'CONTACT', 'email': 'dr.lixiao@163.com', 'phone': '86-10-88326652'}], 'overallOfficials': [{'name': 'Xiao Li, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will not make individual participant data (IPD) available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'San Valley Biotechnology Incorporated', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Thoracic Department', 'investigatorFullName': 'Jun Wang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}