NCT06775574

Brief Summary

This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy. Patients were stratified into the LIPI good group and the intermediate/poor (int./poor) group based on dNLR (≥ 3) and LDH (≥ 245 U/L) levels. Propensity score matching (PSM) was used to adjust for baseline differences and minimize selection bias. Kaplan-Meier survival curves and Cox regression models were employed to evaluate the impact of LIPI and other clinical factors on recurrence-free survival (RFS) and overall survival (OS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
704

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

8.9 years

First QC Date

January 9, 2025

Last Update Submit

January 9, 2025

Conditions

ccRCC

Outcome Measures

Primary Outcomes (2)

  • overall survival (OS)

    5 years

  • recurrence-free survival (RFS)

    5 years

Study Arms (2)

Cohort 1

Patients with dNLR \< 3 and LDH levels below the upper limit of normal

Cohort 2

Patients with dNLR ≥ 3 and LDH levels above the upper limit of normal

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy.

You may qualify if:

  • Pathologically diagnosed with ccRCC;
  • Underwent radical or partial nephrectomy.

You may not qualify if:

  • presence of concurrent malignancies;
  • missing data or failure to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 15, 2025

Study Start

November 1, 2014

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations

CN(1)