Clinical trial NCT05438537: A Comprehensive Prospective Assessment of the Physical and Biological Effects of Upper Tract Urothelial Cancer (UTUC)
Official title: A Comprehensive Prospective Assessment of the Physical and Biological Effects of Upper Tract Urothelial Cancer (UTUC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Upper Tract Urothelial Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 300 Chinese patients with various stage of UTUC will be recruited for the study.

Brief summary: There are many controversies and limitations in the management of Upper Tract Urothelial cancer. A prospective registry is set up for patients in our hospital, aim to have a comprehensive prospective assessment of the physical and biological effects of Upper Tract Urothelial cancer in our patients

Detailed description: Although Upper Tract Urothelial Carcinoma (UTUC) is relatively uncommon, the incidence rate is increasing. There are many controversies and limitations in the management of Upper Tract Urothelial cancer.

In this study, investigators would like to establish a local registry for upper tract urothelial cancer to facilitate the collection of clinical information and outcomes of upper tract urothelial cancer management, and to collect blood, urine and tumour tissue samples to investigate for new diagnostic and therapeutic agents. Hopefully, our registry can provide information regarding the epidemiology, natural history, and treatment outcomes of upper tract urothelial cancer in Hong Kong.

Eligibility criteria: Inclusion Criteria:

* Male patients \> 18 years old
* Patients who has presence of UTUC and pending for surgery
* Patients who has history of UTUC with any intervention performed

Exclusion Criteria:

- Patients fail to provide informed consent

Primary outcomes:
measure: Long-term survival
timeFrame: 10 years
Secondary outcomes:
measure: Recurrence rate of UTUC
timeFrame: 10 years
measure: Progression rate of UTUC
timeFrame: 10 years
measure: Complications
timeFrame: 10 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Jeremy Yuen-Chun TEOH, FRCS(Ed) MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cauberg EC, Salomons MA, Kummerlin IP, de Reijke TM, Zwinderman AH, de la Rosette JJ, Kate FJ, Laguna Pes MP. Trends in epidemiology and treatment of upper urinary tract tumours in the Netherlands 1995-2005: an analysis of PALGA, the Dutch national histopathology registry. BJU Int. 2010 Apr;105(7):922-7. doi: 10.1111/j.1464-410X.2009.08889.x. Epub 2009 Oct 5.
citation: Lughezzani G, Burger M, Margulis V, Matin SF, Novara G, Roupret M, Shariat SF, Wood CG, Zigeuner R. Prognostic factors in upper urinary tract urothelial carcinomas: a comprehensive review of the current literature. Eur Urol. 2012 Jul;62(1):100-14. doi: 10.1016/j.eururo.2012.02.030. Epub 2012 Feb 23.
citation: Mellemgaard A, Carstensen B, Norgaard N, Knudsen JB, Olsen JH. Trends in the incidence of cancer of the kidney, pelvis, ureter and bladder in Denmark 1943-88. Scand J Urol Nephrol. 1993;27(3):327-32. doi: 10.3109/00365599309180442.
citation: Munoz JJ, Ellison LM. Upper tract urothelial neoplasms: incidence and survival during the last 2 decades. J Urol. 2000 Nov;164(5):1523-5.
citation: Remzi M, Shariat S, Huebner W, Fajkovic H, Seitz C. Upper urinary tract urothelial carcinoma: what have we learned in the last 4 years? Ther Adv Urol. 2011 Apr;3(2):69-80. doi: 10.1177/1756287211403349.