Effect and Prognosis of Immunohistochemical Biomarkers Ch... | NCT04966975

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

NCT04966975

Sponsor

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

Status

Unknown status

Last Update Posted

Jul 19, 2021Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Bladder Cancer

Interventions

neoadjuvant chemotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Estimated

Primary Completion Date

Aug 31, 2022Estimated

Completion Date

Aug 31, 2022Estimated

First Submitted Date

Jul 9, 2021

First Submission Date that Met QC Criteria

Jul 16, 2021

First Posted Date

Jul 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2021

Last Update Posted Date

Jul 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

Collaborators

Name	Class
First Affiliated Hospital, Sun Yat-Sen University	OTHER
Third Affiliated Hospital, Sun Yat-Sen University	OTHER
Shantou Central Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Histologically confirmed bladder cancer treated with NAC			Other: neoadjuvant chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neoadjuvant chemotherapy	Other	The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.	Histologically confirmed bladder cancer treated with NAC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of immunohistochemical biomarkers GATA-3, CK20, P53 and Ki67		1 year
Tumor regression grade		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who histologically confirmed bladder cancer treated with neoadjuvant chemotherapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hao Chen	Contact	+86-02034078960		chenh585@mail2.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Jian Huang, MD	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020360	Neoadjuvant Therapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided