Analysis of a New Biomarker for Prostate Cancer Diagnosis | NCT01819740

Studies
Analysis of a New Biomarker for Prostate Cancer Diagnosis

NCT01819740

Sponsor

Corporacion Parc Tauli

Status

Unknown status

Last Update Posted

Mar 28, 2013Estimated

Enrollment

28Estimated

Phase

Not provided

Conditions

Patients With Suspected Prostate Cancer

Interventions

determine the levels of the "HEM" substance in seminal plasma

Countries

Spain

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Apr 2013Estimated

Completion Date

Not provided

First Submitted Date

Mar 25, 2013

First Submission Date that Met QC Criteria

Mar 27, 2013

First Posted Date

Mar 28, 2013Estimated

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

Mar 27, 2013

Last Update Posted Date

Mar 28, 2013Estimated

Description Module

Brief Summary

The aim of our study is to determine if the levels of the "HEM" substance in seminal plasma are associated with the presence of prostate cancer in transrectal prostate biopsy.

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

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with suspected prostate cancer			Other: determine the levels of the "HEM" substance in seminal plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
determine the levels of the "HEM" substance in seminal plasma	Other		patients with suspected prostate cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
substance "HEM" concentration in seminal plasma (mEq/L measured by spectro-photometry		1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical or laboratory suspected of prostate cancer

Exclusion Criteria:

Inability to ejaculate

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Men with clinical or laboratory suspected of prostate cancer attends in Parc Tauli Universitary Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miriam Barrio-Muñoz	Contact	34 93 723 10 10		mbarrio6@gmail.com

Overall Officials

Name	Affiliation	Role
Miriam Barrio-Muñoz	Hospital Universitario Parc Tauli de Sabadell. Spain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Parc Taulí		Sabadell	Barcelona	08208	Spain

Intervention Browse Module

MeSH Terms

ID	Term
D012639	Seeds

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided