Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:50 AM
Study NCT ID:
NCT07452432
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean Prospective Upper Tract Urothelial Carcinoma Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood samples will be collected at two predefined time points: prior to initiation of neoadjuvant chemotherapy and once between 1-6 months after radical nephroureterectomy.\n\nPlasma-derived circulating tumor DNA (ctDNA) will be analyzed using whole-genome sequencing-based copy number variation assessment to estimate tumor fraction.\n\nBiospecimens are collected for research purposes only and will not be used to guide clinical decision-making.\n\nSamples may be stored for future translational analyses related to recurrence monitoring and molecular characterization of upper tract urothelial carcinoma.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-28', 'studyFirstSubmitDate': '2026-02-28', 'studyFirstSubmitQcDate': '2026-02-28', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival (RFS)', 'timeFrame': 'From date of radical nephroureterectomy to first documented recurrence or last follow-up (up to 5 years)', 'description': 'Recurrence is defined as radiographic and/or pathologic evidence of local recurrence, regional nodal recurrence, distant metastasis, or intravesical recurrence documented during routine follow-up.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'From date of surgery to death from any cause or last follow-up (up to 5 years)'}, {'measure': 'Cancer-specific survival (CSS)', 'timeFrame': 'From date of surgery to death due to UTUC or last follow-up (up to 5 years)'}, {'measure': 'ctDNA positivity rate at each time point', 'timeFrame': 'Baseline (pre-NAC) and postoperative 1-6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma (UC)']}, 'descriptionModule': {'briefSummary': 'This is a single-center, prospective, non-interventional observational cohort study designed to establish a structured recurrence monitoring platform in Korean patients with high-grade non-metastatic upper tract urothelial carcinoma (UTUC).\n\nEligible adult patients scheduled to receive neoadjuvant chemotherapy followed by radical nephroureterectomy will undergo circulating tumor DNA (ctDNA) sampling prior to chemotherapy initiation and once between 1-6 months after surgery.\n\nClinical, imaging, pathological, and longitudinal follow-up data will be prospectively collected to enable long-term monitoring of recurrence and survival outcomes.\n\nThe primary objective is to establish a prospective cohort integrating clinical and molecular data to support future translational research and recurrence prediction modeling in UTUC.', 'detailedDescription': 'Upper tract urothelial carcinoma (UTUC) is an aggressive malignancy with a high rate of recurrence and metastatic progression following definitive surgery. Although circulating tumor DNA (ctDNA) has shown promise for minimal residual disease detection and early recurrence monitoring in urothelial carcinoma, prospective data in UTUC, particularly in Asian populations, remain limited.\n\nThis single-center, prospective, non-interventional observational cohort study aims to establish a structured recurrence monitoring cohort in Korean patients with high-grade non-metastatic UTUC. Adult patients with clinical stage cT2-T4, cN0-1, M0 disease who are planned for neoadjuvant chemotherapy followed by radical nephroureterectomy will be enrolled after providing written informed consent.\n\nctDNA blood samples will be collected prior to initiation of neoadjuvant chemotherapy and once between 1-6 months following surgery. All treatment decisions, imaging evaluations, and follow-up assessments will be conducted according to standard clinical practice without protocol-mandated interventions.\n\nDemographic, clinical, imaging, pathological, treatment, and longitudinal outcome data will be prospectively collected for up to five years. The study is designed as a cohort-establishment platform and does not test a predefined interventional hypothesis. The accumulated data will serve as a foundation for future recurrence prediction modeling and precision oncology research in UTUC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Korean patients with high-grade non-metastatic upper tract urothelial carcinoma (cT2-T4, cN0-1, M0) who are candidates for neoadjuvant chemotherapy followed by radical nephroureterectomy at a single tertiary referral center.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 19 years\n\nHistologically confirmed high-grade upper tract urothelial carcinoma (renal pelvis and/or ureter)\n\nClinical stage cT2-T4, cN0-1, M0\n\nPlanned neoadjuvant chemotherapy followed by radical nephroureterectomy\n\nECOG performance status 0-1\n\nAdequate hematologic, hepatic, and renal function\n\nAbility to provide written informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis (M1)\n\nContraindication to cisplatin-based chemotherapy\n\nUncontrolled infection or severe comorbid medical condition\n\nPregnancy or breastfeeding\n\nAny condition that, in the investigator's judgment, makes participation inappropriate"}, 'identificationModule': {'nctId': 'NCT07452432', 'briefTitle': 'Korean Prospective Upper Tract Urothelial Carcinoma Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prospective Establishment of a Recurrence Monitoring Cohort in Korean Patients With Upper Tract Urothelial Carcinoma', 'orgStudyIdInfo': {'id': 'SMC2025-12-074-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High-grade non-metastatic UTUC prospective cohort', 'description': 'Adult patients (≥19 years) with high-grade non-metastatic upper tract urothelial carcinoma (cT2-T4, cN0-1, M0) who are planned for neoadjuvant chemotherapy followed by radical nephroureterectomy will be enrolled in this single-center prospective observational cohort. Peripheral blood will be collected for ctDNA analysis prior to neoadjuvant chemotherapy and once between 1-6 months after surgery. Clinical, imaging, pathological, and longitudinal follow-up data will be prospectively collected for recurrence and survival monitoring.', 'interventionNames': ['Other: Peripheral blood collection for ctDNA analysis']}], 'interventions': [{'name': 'Peripheral blood collection for ctDNA analysis', 'type': 'OTHER', 'description': 'Peripheral blood samples (20-30 mL) will be collected prior to neoadjuvant chemotherapy initiation and once between 1-6 months after surgery for circulating tumor DNA (ctDNA) analysis. No investigational drug or device is administered. All oncologic treatments are conducted according to standard clinical practice.', 'armGroupLabels': ['High-grade non-metastatic UTUC prospective cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jiwoong Yu', 'role': 'CONTACT', 'email': 'jiwoong082.yu@samsung.com', 'phone': '+82234103559'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jiwoong Yu, MD', 'role': 'CONTACT', 'email': 'jiwoong082.yu@samsung.com', 'phone': '+82234103559'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Byong Chang Jeong', 'investigatorAffiliation': 'Samsung Medical Center'}}}}