Patients With Suspected Prostate CancerHEMNCT01819740
Analysis of a New Biomarker for Prostate Cancer Diagnosis
An observational study of Patients With Suspected Prostate Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Patients With Suspected Prostate Cancer
- What is being tested?
- determine the levels of the "HEM" substance in seminal plasma
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with clinical or laboratory suspected of prostate cancer attends in Parc Tauli Universitary Hospital.
Who may be able to join
- Clinical or laboratory suspected of prostate cancer
Who cannot join
- Inability to ejaculate
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Parc Taulí
Sabadell, Barcelona, 08208
Miriam Barrio-Muñoz
About this study
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.
- Conditions
- Patients With Suspected Prostate Cancer
- Being tested
- determine the levels of the "HEM" substance in seminal plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determine the levels of the "HEM" substance in seminal plasmaOther
| Study group | Role | What they receive |
|---|---|---|
| patients with suspected prostate cancer | Not described Receives: Other: determine the levels of the "HEM" substance in seminal plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
substance "HEM" concentration in seminal plasma (mEq/L measured by spectro-photometry
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Suspected Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MIRIAM BARRIO MUÑOZ, Hospital de Sabadell
- Investigators
- Miriam Barrio-Muñoz, Principal investigator, Hospital Universitario Parc Tauli de Sabadell. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819740
- Sponsor's protocol ID
- CSPT/URO/2013/PROSTATE
- Acronym
- HEM
- Status last verified
- Mar 2013
- First submitted
- 25 Mar 2013
- Last updated
- 28 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of a New Biomarker for Prostate Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT01819740
- Acronym / sponsor ID
- HEM / CSPT/URO/2013/PROSTATE
- Conditions
- Patients With Suspected Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2013 (estimated)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with suspected prostate cancer | – | Other: determine the levels of the "HEM" substance in seminal plasma |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with clinical or laboratory suspected of prostate cancer attends in Parc Tauli Universitary Hospital.
Key inclusion criteria (1 listed)
- Clinical or laboratory suspected of prostate cancer
Key exclusion criteria (1 listed)
- Inability to ejaculate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| determine the levels of the "HEM" substance in seminal plasma | Other | patients with suspected prostate cancer |
Primary outcome
substance "HEM" concentration in seminal plasma (mEq/L measured by spectro-photometry
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Barrio-Muñoz principal investigator
Hospital Universitario Parc Tauli de Sabadell. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Suspected Prostate Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Barrio-Muñoz (34 93 723 10 10, mbarrio6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
substance "HEM" concentration in seminal plasma (mEq/L measured by spectro-photometry (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.