Carcinoma, Transitional Cell (RENI)NCT06305130
Prognostic Value of Performance Scores in Patients Undergoing Surgery for Upper Tract Urothelial Carcinoma
An observational study of Carcinoma, Transitional Cell (RENI), run by Kaohsiung Medical University.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Transitional Cell (RENI)
- How many people
- 2,515 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1988to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients received UTUC surgery and follow-up in sixteen institutions across Taiwan
Who cannot join
- Treatment not aimed at curative intent
- Incomplete data
About this study
Official 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
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
Read the 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.
- Conditions
- Carcinoma, Transitional Cell (RENI)
- Being tested
- No intervention
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
in days
Measured: 1988 to 2023
Cancer-specific survival
in days
Measured: 1988 to 2023
Disease-free survival
in days
Measured: 1988 to 2023
Bladder recurrence-free survival
in days
Measured: 1988 to 2023
Secondary outcomes (2)
Number of patients with major postoperative complication
Clavien-Dindo classification grade higher or equal to III
Measured: 1988 to 2023
Number of patients with postoperative renal failure
Those who requiring renal replacement therapy permanently
Measured: 1988 to 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jan 1988
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Transitional Cell (RENI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Chih Yeh, Kaohsiung Medical University
- Investigators
- Hsin-Chih Yeh, MD, PhD, Principal investigator, Department of Urology, Kaohsiung Medical University, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305130
- Sponsor's protocol ID
- KMUHIRB-E(I)-20180214
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06305130
- Acronym / sponsor ID
- KMUHIRB-E(I)-20180214
- Conditions
- Carcinoma, Transitional Cell (RENI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,515 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 1988 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary cohort (only one in this study) | – | Other: No interventionPatient 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients received UTUC surgery and follow-up in sixteen institutions across Taiwan
Key exclusion criteria (2 listed)
- Treatment not aimed at curative intent
- Incomplete data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Primary cohort (only one in this study) |
Primary outcome
Overall survival
Time frame: 1988 to 2023
in days
Cancer-specific survival
Time frame: 1988 to 2023
in days
Disease-free survival
Time frame: 1988 to 2023
in days
Bladder recurrence-free survival
Time frame: 1988 to 2023
in days
2 secondary outcomes
Number of patients with major postoperative complication
Time frame: 1988 to 2023
Number of patients with postoperative renal failure
Time frame: 1988 to 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsin-Chih Yeh, MD, PhD principal investigator
Department of Urology, Kaohsiung Medical University, Kaohsiung, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Transitional Cell (RENI), run by Kaohsiung Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1988 to 2023). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.