Prognostic Value of Performance Scores in Patients Undergoing Surgery for Upper Tract Urothelial Carcinoma

March 7, 2024 updated by: Hsin-Chih Yeh, Kaohsiung Medical University

Prognostic Value of Eastern Cooperative Oncology Group Performance Status and American Society of Anesthesiologists Score in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma

Aim: to comprehensively evaluate the prognostic value of preoperative ECOG-PS scores and ASA scores in patients undergoing radical nephroureterectomy (RNU) for upper tract urothelial carcinoma.

Methods: multicentered cohort study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score and the American Society of Anesthesiologists (ASA) score are essential tools for the assessment of patients with various malignancies. However, doubts have arisen regarding their prognostic utility due to conflicting findings in limited studies. This study aims to comprehensively evaluate the prognostic value of preoperative ECOG-PS scores and ASA scores in patients undergoing radical nephroureterectomy (RNU) for upper tract urothelial carcinoma.

Materials and Methods:

This multicentered cohort study enrolled patients who underwent RNU with curative intentat sixteen institutes in Taiwan from 1988 to 2023. Univariable and multivariable regression analyses were used to determine the impact of ECOG-PS scores and ASA scores on survival outcomes and postoperative complications. Patients were categorized based on ECOG-PS scores (0-1 vs. 2-4) and ASA scores (1-2 vs.3-4) according to prior literature.

Study Type

Observational

Enrollment (Actual)

2515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with UTUC and underwent RNU between 1988 and 2023, and a total of 2515 eligible patients were included in the final analysis.

Description

Inclusion Criteria:

  • All patients received UTUC surgery and follow-up in sixteen institutions across Taiwan

Exclusion Criteria:

  • Treatment not aimed at curative intent
  • Incomplete data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary cohort (only one in this study)
Patient data were collected from sixteen institutions across Taiwan, encompassing 6005 patients diagnosed with UTUC between 1988 and 2023. The study included all patients who underwent RNU with curative intent. After excluding those with incomplete data, a total of 2515 eligible patients were included in the final analysis.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1988 to 2023
in days
1988 to 2023
Cancer-specific survival
Time Frame: 1988 to 2023
in days
1988 to 2023
Disease-free survival
Time Frame: 1988 to 2023
in days
1988 to 2023
Bladder recurrence-free survival
Time Frame: 1988 to 2023
in days
1988 to 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with major postoperative complication
Time Frame: 1988 to 2023
Clavien-Dindo classification grade higher or equal to III
1988 to 2023
Number of patients with postoperative renal failure
Time Frame: 1988 to 2023
Those who requiring renal replacement therapy permanently
1988 to 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University

Investigators

  • Principal Investigator: Hsin-Chih Yeh, MD, PhD, Department of Urology, Kaohsiung Medical University, Kaohsiung, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1988

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-E(I)-20180214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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