Clinical Validation of the Prognostic Value of the PrTS on Prostate Cancer Patients

NCT05248282 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-02-21

No results posted yet for this study

Summary

Prostate Cancer is the most common type of cancer among men in many countries. However current clinical tools have limited prediction accuracy to choose the optimal treatment for the individual patient, as prostate cancer risk assessment is a critical aspect of treatment decision-making. A substantial proportion of patients are undergoing over-treatment such as radical treatment, which is often associated with negative physical and psychological side effects, dramatically affecting quality of life in a negative way. Moreover, the patients that are under-treated will face higher cancer mortality risks, which brings more concerns for patients and doctors. Prostatype composes a one-step 4-plex quantitative reverse transcription polymerase chain reaction kit, a database based on authenic patients information and a score system (P-score), intended to measure gene expression levels of three biomarkers: IGFBP3, F3 and VGLL3. Genetic values combined with clinical parameters in the CPMA and P-score are aiming to estimate the aggressiveness of prostate tumor for a newly diagnosed prostate cancer patient. This is a single-center, retrospective, blinded validation study aim to investigate the prognostic performance of the Prostatype test system.

Conditions

Sponsors & Collaborators

  • Prostatype Genomics AB

    collaborator UNKNOWN
  • GloriousMed Clinical Laboratory (Shanghai) Co., Ltd.

    collaborator UNKNOWN
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-04-30
Completion
2022-12-31

Countries

  • China

Study Locations

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Entities

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 NCT05248282 on ClinicalTrials.gov