NCT06245759

Brief Summary

Based on large sample size studies at home and abroad, the prognosis of patients with non-muscular invasive bladder cancer in different sites undergoing transurethral bladder tumor resection was determined, providing important guidance for subsequent clinical treatment and surgical instrument development.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

August 31, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

January 23, 2024

Last Update Submit

January 30, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Overall survival time

    OS, defined as the time from the first diagnosis to death from any cause or the last follow-up for surviving patients

    up to 20 years

  • Recurrence free survival time

    Recurrence-free survival (RFS) is the time from the time a patient achieved complete response after antineoplastic therapy to the time of recurrence or the end of follow-up. The longer the relapse-free survival time, the better the efficacy of anti-tumor therapy.

    up to 16 years

Study Arms (2)

the U.S. National Cancer Center SEER database

The Chinese NMIBC cohort includes patients from January 1996 to December 2019 at 15 institutions.

Other: This was a retrospective study and no patient intervention was performed

the Chinese Bladder Cancer Alliance CBCC database

SEER\*Stat software (version 8.4.1.1) collected 17 registries cohort data on NMIBC patients diagnosed between 2000 and 2020.

Other: This was a retrospective study and no patient intervention was performed

Interventions

This was a retrospective study and no patient intervention was performed

the Chinese Bladder Cancer Alliance CBCC databasethe U.S. National Cancer Center SEER database

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study utilized the Chinese NMIBC cohort as well as the SEER 17 registries cohort for its investigation. The Chinese NMIBC cohort contains data of patients between January 1996 and December 2019, at 14 institutions. SEER\*Stat software (version 8.4.1.1) was used for collecting 17 registries cohort data on patients diagnosed with NMIBC between 2000 and 2020.

You may qualify if:

  • Initially diagnosed with non-muscular invasive bladder cancer (NMIBC) who underwent TURBT or partial cystectomy.
  • The follow-up data of the patients were complete.
  • The tumor location information were complete.

You may not qualify if:

  • Patients with unknown survival time or missing tumor location information were excluded.
  • Exclude patients with missing pathological results.
  • Exclude patients who have had TURBT before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ke Chen

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (1)

  • Liu L, Li K, Wang SG, Wang J, Yao Z, Xie Y, Ji Z, Chen Z, Hu H, Chen H, Hu J, Hou Y, Liu Z, Li Y, Ding Y, Kuang Y, Xun Y, Hu J, Zhang J, Li H, Chong T, Bi J, Wang Z, Wang Y, Zhang P, Wei Q, Chen Z, Li L, Huang J, Liu Z, Chen K; Chinese Bladder Cancer Consortium. The prognostic impact of tumor location in nonmuscle-invasive bladder cancer patients undergoing transurethral resection: insights from a cohort study utilizing Chinese multicenter and SEER registries. Int J Surg. 2024 Sep 1;110(9):5641-5651. doi: 10.1097/JS9.0000000000001675.

MeSH Terms

Conditions

Non-Muscle Invasive Bladder NeoplasmsUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Ke Chen, MD/PhD

    Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 7, 2024

Study Start

August 31, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 7, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations