NCT02969109

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
417

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

November 14, 2016

Last Update Submit

February 26, 2021

Conditions

Non-muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (2)

  • The recurrence status based on the pathology results

    1 year

  • The Genomic Health bladder cancer assay results.

    1 year

Eligibility Criteria

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

Non-muscle invasive bladder cancer patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Prostate and Urologic Cancers - University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and tissue

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

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

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 21, 2016

Study Start

October 1, 2015

Primary Completion

September 18, 2018

Study Completion

September 18, 2018

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)