Identifying Methylation Biomarkers for Monitoring Bladder... | NCT00244205

Studies
Identifying Methylation Biomarkers for Monitoring Bladder Tumors

NCT00244205

Sponsor

Copenhagen University Hospital at Herlev

Status

Unknown status

Last Update Posted

Nov 15, 2005Estimated

Enrollment

120

Phase

Not provided

Conditions

Bladder Cancer

Interventions

Identifying genes methylated in urine

Countries

Denmark

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

Nov 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 24, 2005

First Submission Date that Met QC Criteria

Oct 24, 2005

First Posted Date

Oct 26, 2005Estimated

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

Nov 14, 2005

Last Update Posted Date

Nov 15, 2005Estimated

Description Module

Brief Summary

To investigate the methylation status of 4-6 genes in Urine and matching bladder tissue biopsies, in order to find methylation markers for use in a noninvasive test in monitoring patients with bladder tumors.

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

Not provided

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

120

Name	Type	Description	Arm Group Labels	Other Names
Identifying genes methylated in urine	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with bladder tumors and patients with benign urinary tract conditions with no clinical suspicion of bladder cancer.

Exclusion Criteria:

Patients with competing urinary and systemic diseases, pregnant and patients under 18 years of age.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reza R Serizawa, MD	Contact	+45 44884787	82607	rerase01@herlevhosp.kbhamt.dk
Jørgen H Andersen	Contact			johvan01@herlevhosp.kbhamt.dk

Overall Officials

Name	Affiliation	Role
Reza R Serizawa, MD	Copenhagen University Hospital at Herlev	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital at Herlev	Recruiting	Herlev	Copenhagen	2730	Denmark

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
D014554	Urination

Ancestor Terms

ID	Term
D014553	Urinary Tract Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided