NCT02027649

Brief Summary

By an invasive technique keratin 14 has been identified as a prognostic factor in bladder cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be used as a diagnostic and prognostic marker for this cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

January 3, 2014

Last Update Submit

July 18, 2017

Conditions

Bladder Cancer

Keywords

Bladder cancerKeratin 14Pronostic markerDiagnostic markerNoninvasive technique

Outcome Measures

Primary Outcomes (1)

  • Keratin 14

    At the time of study entry

Study Arms (2)

Bladder cancer

Patients who suffered a bladder cancer

Control group

Patients with urologic diseases of non tumoral origin

Eligibility Criteria

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

Hospital patients.

You may qualify if:

  • Bladder cancer

You may not qualify if:

  • Inability to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporació Sanitària i Universitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 6, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

May 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

ES(1)