Viewing Study NCT04702633


Ignite Creation Date: 2025-12-25 @ 2:45 AM
Ignite Modification Date: 2025-12-26 @ 1:25 AM
Study NCT ID: NCT04702633
Status: COMPLETED
Last Update Posted: 2025-11-20
First Post: 2021-01-07
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Immuno-molecular Approaches for Non-invasive Diagnosis of Prostate Cancer
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization:

Study Overview

Official Title: Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis
Status: COMPLETED
Status Verified Date: 2025-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PROSTA-PAP
Brief Summary: The purpose of this study is to isolate and characterize tumor cells non-invasively from biological samples in patients with prostate cancer and demonstrate the ability to identify the presence and number of tumor cells before prostate biopsy.
Detailed Description: Prostate cancer is one of the most frequently diagnosed cancers and a leading cause of cancer death in men worldwide. Existing methods of diagnosis and monitoring of prostate cancer are inadequate due to their invasiveness, inaccuracy, cost, access uneven, etc., making difficult the diagnosis and patient's follow up. New techniques and methods are necessary to improve diagnosis.

Biological liquids might represent an attractive target to isolate prostate tumour cells for these purposes. In recent years, several studies have been carried out with the aim of reducing and / or avoiding the limits of sensitivity and specificity of current methods of screening for prostate cancer and thus obtain new biomarkers for the diagnosis and / or non-invasive monitoring.

However, due to technical and technological difficulties few studies have been performed to investigate the non-invasive isolation and direct analysis of tumour cells. Our project is therefore an innovative project which aims to study a new approach for the early diagnosis of prostate cancer, with better sensitivity and specificity.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: