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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 February 2024 |
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Main ID: |
NCT02607709 |
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Date of registration:
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15/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lymphadenectomy in Urothelial Carcinoma
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Scientific title:
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Lymphadenectomy in Urothelial Carcinoma in the Renal Pelvis and Ureter |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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366 |
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Recruitment status: |
Suspended |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02607709 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Nessn H Azawi, MB.Ch.B. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Roskilde University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age above 18 years
2. Locally advanced high grade urothelial carcinoma in the renal pelvis or upper 2/3 of
the ureter (Clinical stage > T1)
3. Patient with ECOG performance score of 2 and less.
4. Able to give informed consent
Exclusion Criteria:
1. Clinical suspicion of non-muscle invasive UUTUC
2. Metastatic urothelial carcinoma for the renal pelvis or upper 2/3 of the ureter
3. Inability to understand written consent forms or give consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ureteral Neoplasms
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Intervention(s)
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Procedure: Lymphadenectomy in conjugation with nephroureterectomy
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Procedure: Nephroureterectomy without lymphadenectomy
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Primary Outcome(s)
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Recurrence free survival
[Time Frame: Five years]
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Secondary Outcome(s)
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Incidence of metastasis
[Time Frame: Five years]
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Secondary ID(s)
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REG-79-2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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