CD155 in Bladder Cancer | NCT03789682

Studies
CD155 in Bladder Cancer

NCT03789682

Sponsor

Fudan University

Status

Completed

Last Update Posted

Apr 16, 2025Actual

Enrollment

151Actual

Phase

Not provided

Conditions

Bladder Cancer

Interventions

Adjuvant chemotherapy

Countries

China

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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Jan 1, 2025Actual

First Submitted Date

Dec 27, 2018

First Submission Date that Met QC Criteria

Dec 27, 2018

First Posted Date

Dec 28, 2018Actual

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

Apr 13, 2025

Last Update Posted Date

Apr 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This research is designed to investigate the prognostic and predictive value of CD155 in muscle invasive bladder cancer.

Detailed Description

Not provided

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

151Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FUSCC cystectomy cohort		patients underwent cystectomy in Fudan University Shanghai Cancer Center	Drug: Adjuvant chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adjuvant chemotherapy	Drug	adjuvant chemotherapy using Gemcitabine plus Cisplatin	FUSCC cystectomy cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence free survival	Time to recurrence or metastasis	2018.1.1-2023.12.31

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	Time to death	2018.1.1-2028.1.1
Benefit from neoadjuvant chemotherapy	response to neoadjuvant chemotherapy	2018.1.1-2028.1.1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with non-metastatic muscle invasive bladder cancer
pathology confirmed urothelial carcinoma
underwent cystectomy and pelvic lymph node dissection

Exclusion Criteria:

not enough tissue for immunohistochemistry
patients with a second neoplasm

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

patients with non-metastatic muscle invasive bladder cancer underwent cystectomy in Fudan University Shanghai Cancer Center is included

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center		Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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
D017024	Chemotherapy, Adjuvant

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy

Browse Leaves

Not provided

Browse Branches

Not provided