Effect and Prognosis of Immunohistochemical Biomarkers Changes in Patients With Bladder Cancer After Neoadjuvant Chemotherapy

• Conditions: Bladder Cancer
• Interventions: Other: neoadjuvant chemotherapy

• Registration Number: NCT04966975
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

This is a retrospective study included bladder cancer patients treated with neoadjuvant chemotherapy. We analyzed the changes in the expression of GATA-3, CK20, P53 and Ki67 before and after NAC. Evaluating the sensitivity factor for predicting pathological complete response.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-16
• Study First Posted: 2021-07-19
• Last Update Posted: 2021-07-19
• Study Start: 2021-09-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Histologically confirmed bladder cancer treated with NAC	neoadjuvant chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Tumor regression grade	1 year
Expression of immunohistochemical biomarkers GATA-3, CK20, P53 and Ki67	1 year