NCT04966975

Brief Summary

Clinical trial to investigate the relationship between the expression of immunohistochemical biomarkers GATA-3, CK20, P53 and Ki67 in bladder cancer and pathological complete response after neoadjuvant chemotherapy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

July 9, 2021

Last Update Submit

July 16, 2021

Conditions

Bladder Cancer

Keywords

bladder cancerneoadjuvant chemotherapyimmunohistochemical biomarkers

Outcome Measures

Primary Outcomes (2)

  • Expression of immunohistochemical biomarkers GATA-3, CK20, P53 and Ki67

    1 year

  • Tumor regression grade

    1 year

Study Arms (1)

Histologically confirmed bladder cancer treated with NAC

Other: neoadjuvant chemotherapy

Interventions

neoadjuvant chemotherapyOTHER

The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.

Histologically confirmed bladder cancer treated with NAC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who histologically confirmed bladder cancer treated with neoadjuvant chemotherapy.

You may qualify if:

  • Any male or female patient aged 18 or older.
  • Histologically confirmed bladder cancer, cystectomy was performed after NAC.
  • Complete clinical data.

You may not qualify if:

  • Patients with severe organic disease who can not tolerate chemotherapy or surgery
  • Patients received previous treatment (chemotherapy, radiation, or molecular targeted therapy).
  • Patients with distant metastasis or other cancer history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Jian Huang, MD

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Chen

CONTACT

+86-02034078960chenh585@mail2.sysu.edu.cn

Study Design

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

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 19, 2021

Study Start

September 1, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share