Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509919
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Application of a Model Based on Plasma cfDNA Fragmentomics in the Early Diagnosis of Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this diagnostic test is to obtain multiple cell-free DNA cfDNA fragment profiles of subjects by whole genome sequencing based on plasma cfDNA build a prostate cancer prediction model by machine learning and to validate the efficacy of this model in patients who need to undergo needle prostate biopsy base on their prostate-specific antigenPSA or clinical or imaging evidence Therefore this study aims to explore the efficacy of this prostate cancer prediction model in distinguishing between patients with PSA gray zone 4-10 ngml in the diagnosis of prostate cancer and patients with clinically significant prostate cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None