Observational Study of Patients Who Underwent Diagnostic Investigation (Prostate Biopsy) and/or Radical Prostatectomy Surgery.

NCT ID: NCT06397755

Last Updated: 2024-05-03

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

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-08

Study Completion Date

2065-01-08

Brief Summary

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This is a single-center, observational, prospective and retrospective study on quality of life and disease status of patients who underwent prostate biopsy and/or radical prostatectomy.

Detailed Description

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A database was created with the intention of collecting data related to patients who underwent prostate biopsy and/or radical prostatectomy.

Only anamnesis and biopsy procedure data are collected for patients underwent prostate biopsy.

Anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy.

Each patient will be followed for 50 years from the date of radical prostatectomy surgery.

Each patient will receive a questionnaire before radical prostatectomy. A follow up questionnaire will be collected after surgery relating to quality of life. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients underwent prostate biopsy and/or radical prostatectomy surgery.

Prostate Biopsy and/or Radical Prostatectomy

Intervention Type PROCEDURE

Prostate Biopsy: procedure to remove samples of suspicious tissue from the prostate Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis

Interventions

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Prostate Biopsy and/or Radical Prostatectomy

Prostate Biopsy: procedure to remove samples of suspicious tissue from the prostate Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with a suspicious prostate disease who underwent prostate biopsy and/or radical prostatectomy;
* Adult patients \> 18 years
* Ability to read and sign the informed consent

Exclusion Criteria

* Patients \< 18 years
* mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
* Inability to read and sign the informed consent
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Andrea Salonia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Salonia

Role: CONTACT

+39 0226435661

Facility Contacts

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Andrea Salonia

Role: primary

+390226435661

Nadia Finocchio

Role: backup

+39 0226439425

Other Identifiers

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2014-Prostata

Identifier Type: -

Identifier Source: org_study_id

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