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Completed

NCT Number: NCT06305130

Prognostic Value of Performance Scores in Patients Undergoing Surgery 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

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Key information

Conditions

Carcinoma, Transitional Cell (RENI) Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Overall survival

    Time frame: 1988 to 2023

    in days

  2. Cancer-specific survival

    Time frame: 1988 to 2023

    in days

  3. Disease-free survival

    Time frame: 1988 to 2023

    in days

  4. Bladder recurrence-free survival

    Time frame: 1988 to 2023

    in days

Secondary outcomes

  1. Number of patients with major postoperative complication

    Time frame: 1988 to 2023

    Clavien-Dindo classification grade higher or equal to III

  2. Number of patients with postoperative renal failure

    Time frame: 1988 to 2023

    Those who requiring renal replacement therapy permanently

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Registry information

Official study title

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

Important dates

Study start
1988
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2024
Registry last updated
Mar 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.

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