Prostate Impendance Test Project

NCT ID: NCT03428087

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-06-30

Brief Summary

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Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods will be subjected to impedance measurement. Aim of this study is to be able to structure a bivariate analysis of the distribution of impedances detected in patients with neoplasia in order to detect test median reference values.

Detailed Description

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Conditions

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Prostatic Neoplasms PSA Prostatic Biopsy Impedance Test

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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patients undergoing prostatic biopsy

Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. age\> 45 years
2. up of total PSA values beyond the normal range (\> 4 ng / ml)
3. presence or absence of suspicious prostate nodule

Exclusion Criteria

1. previous history of cancer
2. BMI\>30
3. patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Prof. Riccardo Bartoletti

Prostate Impedance Test (PROS.iT) Project in prostate cancer diagnosis: a cross-sectional observational study

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOUP Ospedale cisanello

Pisa, Tuscany, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Tommaso Di Vico, Resident

Role: CONTACT

3393642655

Facility Contacts

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Tommaso Di Vico, MD

Role: primary

3393642655

Other Identifiers

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151/2016

Identifier Type: -

Identifier Source: org_study_id

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