Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06204406

Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

Upper tract urothelial carcinoma (UTUC) is a rare malignant disease which accounts for 5-10% of urothelial carcinoma in the western world and 9%-30% in China. About two thirds of patients have muscle invasive disease at diagnosis. Those patients usually have poor prognosis. The 5 year cancer specific survival is <50% for pT2/T3 and <10% for pT4. Radical nephroureterectomy is the standardized treatment for non-metastatic high risk UTUC. However, about half patients may suffer from impaired renal function after nephroureterectomy. On the other hand, kidney sparing surgery can avoid renal function impairment, but the therapy is only recommended for few patients with low-risk disease. The treatment for urothelial carcinoma has changed rapidly in the past few years. Immune checkpoint inhibitors and novel agents such as ADCs have shown promising therapeutic effect and were approved for patients with metastatic UTUC. Meanwhile, a recent study shows that patients with high-risk disease can also receive kidney sparing surgery without compromising cancer specific survival and overall survival. This prospective, observational study aims to evaluate the prognosis of contemporary kidney sparing surgery in patients with UTUC with or without perioperative therapy in the real world.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Renji Hospital

Shanghai, Shanghai Municipality, 200123, China

Location status: Recruiting

Location contact

Jiwei Huang, Dr

CONTACT

[email protected]

8621-68383544

About this study

The patients that meet the Inclusion and Exclusion Criteria will enroll into this observational trial. The therapeutic schedule is purposed to spare the kidney of non-metastatic primary UTUC patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Minimum Age: 18 Years Maximum Age: 90 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No

Criteria:

Inclusion criteria

  • Histopathological confirmed upper tract urothelial carcinoma;
  • Refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery;
  • Participants must be willing to attend the follow-up visits;
  • Sign informed consent.

Exclusion criteria

  • Unable to undergo kidney-sparing surgery;
  • Life expectancy < 6 months;
  • Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.

Treatment and study plan

Observational

Other

This is a prospective observational study with observation only and no intervention

Primary outcomes

  1. Two-year events-free survival rate

    Time frame: Up to 2 years

    events-free survival defined as time from initiation of first protocol therapy until the first time to develop any local recurrence (local/bladder), distant metastases or any cause-related death.

Secondary outcomes

  1. Overall survival

    Time frame: Up to 2 years

    defined as time from initiation for protocol therapy to death.

  2. Metastasis free surviva

    Time frame: Up to 2 years

    metastasis free survival defined as time from initiation of protocol therapy until the development of distal metastasis or death

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Up to 2 years

    The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) 5.0..

Study contacts

Contact information is provided by the study sponsor or research team.

Jiwei Huang, Dr

CONTACT

[email protected]

8613651682825

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University
  • Ruijin Hospital
  • Shanghai Zhongshan Hospital
  • The First Affiliated Hospital of University of Science and Technology of China
  • The Second Hospital of Anhui Medical University
  • Tianjin Medical University Second Hospital
  • West China Hospital
  • Xiangya Hospital of Central South University
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

A Multicenter, Prospective, Observational Clinical Study to Evaluate the Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 12, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.