NCT01264744

Brief Summary

The purpose of the study is the identification of chromosomal aberrations in urine samples. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of UroVysion FISH stained Urine samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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

November 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
Last Updated

December 23, 2010

Status Verified

December 1, 2010

Enrollment Period

9 months

First QC Date

December 21, 2010

Last Update Submit

December 22, 2010

Conditions

Bladder Cancers

Keywords

Bladder cancerChromosomal aberrationsFISHUrine sample

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with hematuria that are suspected in having bladder carcinoma, and in patients previously diagnosed with bladder cancer.

You may qualify if:

  • Well stained slides with bright FISH signals

You may not qualify if:

  • Very old slides that were already bleached

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Hospital

Los Angeles, California, 90073, United States

Location

PLUS Diagnostics

Union, New Jersey, 07083, United States

Location

Sheila Dobin, Ph.D.

Temple, Texas, 76508, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Urinary Bladder NeoplasmsChromosome Aberrations

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sheila - Dobin, Ph.D.

    Section Chief, Cytogenetics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 22, 2010

Study Start

November 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 23, 2010

Record last verified: 2010-12

Locations

US(3)