Validation of a Urine-based Assay With Genomic Markers fo... | NCT02969109

Studies
Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer

NCT02969109

Sponsor

Genomic Health®, Inc.

Status

Completed

Last Update Posted

Mar 2, 2021Actual

Enrollment

417Actual

Phase

Not provided

Conditions

Non-muscle Invasive Bladder Cancer

Interventions

Not provided

Countries

United States

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

Feb 2021

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

Oct 2015Actual

Primary Completion Date

Sep 18, 2018Actual

Completion Date

Sep 18, 2018Actual

First Submitted Date

Nov 14, 2016

First Submission Date that Met QC Criteria

Nov 17, 2016

First Posted Date

Nov 21, 2016Estimated

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

Feb 26, 2021

Last Update Posted Date

Mar 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A study to validate, in a prospective manner, the ability of the predefined Genomic Health bladder cancer assay to detect recurrence in patients undergoing surveillance for non-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

Retention

Enrollment

417Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The recurrence status based on the pathology results		1 year
The Genomic Health bladder cancer assay results.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a prior diagnosis of non-muscle invasive, ≤T1, urothelial cell carcinoma of the bladder scheduled to undergo surveillance cystoscopy.

Exclusion Criteria:

Patients younger than 18 years
Patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell carcinoma of the bladder
Patients who have had a cystectomy or prior diagnosis of muscle invasive disease (T2 or greater)
Patients who are unable or unwilling to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Non-muscle invasive bladder cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Prostate and Urologic Cancers - University of Minnesota		Minneapolis	Minnesota	55455	United States

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
D000093284	Non-Muscle Invasive Bladder Neoplasms

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided