A Comprehensive Prospective Assessment of the Physical an... | NCT05438537

Studies
A Comprehensive Prospective Assessment of the Physical and Biological Effects of Upper Tract Urothelial Cancer (UTUC)

NCT05438537

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

Jan 23, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Upper Tract Urothelial Cancer

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Actual

Primary Completion Date

Dec 30, 2030Estimated

Completion Date

Dec 30, 2030Estimated

First Submitted Date

Jun 24, 2022

First Submission Date that Met QC Criteria

Jun 29, 2022

First Posted Date

Jun 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2024

Last Update Posted Date

Jan 23, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeremy Yuen Chun TEOH, Assistant Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term survival	Long-term survival	10 years

Secondary Outcomes

Measure	Description	Time Frame
Recurrence rate of UTUC	Recurrence rate of UTUC	10 years
Progression rate of UTUC	Progression rate of UTUC	10 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A total of 300 Chinese patients with various stage of UTUC will be recruited for the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeremy Yuen-Chun TEOH, FRCS(Ed)	Contact	3505-2625		jeremyteoh@surgery.cuhk.edu.hk

Overall Officials

Name	Affiliation	Role
Jeremy Yuen-Chun TEOH, FRCS(Ed) MBBS	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital	Recruiting	Hong Kong			Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19804428	Background	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.
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