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Factors Associated With PSA False Negative and False Positive Results and the Impact on Patient's Health.

NCT03978299 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2527

Last updated 2019-06-11

No results posted yet for this study

Summary

Objectives:

The primary aim of this study is to evaluate the outcomes of the determination of PSA for the early detection of prostate cancer or in the presence of symptoms, in general practice in two health departments of the Valencian Community (Spain).

Specific objectives:

1. To analyse the clinical and analytical factors associated with the presence of false positive and false negative results in PSA determinations in patients within the setting of opportunistic screening and in those with symptoms.
2. To evaluate the patient's clinical outcome, diagnostic and/or clinical and/or therapeutic interventions implemented in each patient according to the PSA value and the patient's clinical variables during the two years of follow-up. Furthermore, the investigadors will study whether this management is appropriate to the recommendations of the European Society of Urology.

Conditions

  • Prostate-Specific Antigen /Blood

Interventions

DIAGNOSTIC_TEST

Positive Prostate-Specific Antigen test result

Positive PSA test result as part of opportunistic screening or due to the presence of symptoms suggestive of disease.

Sponsors & Collaborators

  • Hospital Universitario San Juan de Alicante

    collaborator OTHER

  • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    collaborator OTHER

  • Universidad Miguel Hernandez de Elche

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978299 on ClinicalTrials.gov