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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05438537
Collaborator
(none)
300
1
109.9
2.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Comprehensive Prospective Assessment of the Physical and Biological Effects of Upper Tract Urothelial Cancer (UTUC)
    Actual Study Start Date :
    Nov 1, 2021
    Anticipated Primary Completion Date :
    Dec 30, 2030
    Anticipated Study Completion Date :
    Dec 30, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Long-term survival [10 years]

      Long-term survival

    Secondary Outcome Measures

    1. Recurrence rate of UTUC [10 years]

      Recurrence rate of UTUC

    2. Progression rate of UTUC [10 years]

      Progression rate of UTUC

    3. Complications [10 years]

      Complications are assessed by medical record and on patient follow up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: Jeremy Yuen-Chun TEOH, FRCS(Ed) MBBS, Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jeremy Yuen Chun TEOH, Assistant Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05438537
    Other Study ID Numbers:
    • CRE 2020.484
    First Posted:
    Jun 30, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 30, 2022