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NCT Number: NCT06707974

Prognostic Study of Via Dynamic Change of dT-DNA in Drainage Fluid After Radical Prostatectomy

This study investigates the prognostic value of dynamic changes in Drainage Tumor DNA(dT-DNA) levels found in the peritoneal drainage fluid after radical prostatectomy. Prostate cancer is one of the most common cancers in men, and radical prostatectomy is a standard treatment. While PSA levels in the blood are commonly used as a marker for diagnosis, this study focuses on the significance of dT-DNA levels in the prognosis of prostate cancer. The findings may provide insights into improved post-surgical monitoring and more tailored therapeutic strategies for prostate cancer patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

About this study

This study examines the prognostic significance of dT-DNA levels in the peritoneal drainage fluid following radical prostatectomy, a common surgical treatment for prostate cancer. PSA is widely used as a biomarker for prostate cancer diagnosis, treatment response, and recurrence monitoring in the blood. However, this research seeks to explore the prognostic value of dT-DNA in the drainage fluid.

The study involves continuous monitoring of dT-DNA levels in the drainage fluid after radical prostatectomy, with the hypothesis that dynamic changes in these levels could serve as an early warning system for potential tumor recurrence, residual disease, or metastasis. The research will correlate these fluid dT-DNA levels with patient outcomes, recurrence rates, and other clinical factors to determine their predictive value.

By investigating this novel source of dT-DNA monitoring, the study aims to reduce invasive tests, enhance post-operative surveillance, and improve early detection of disease recurrence for prostate cancer patients. This research could contribute to refining post-surgical care protocols, offering a new tool for predict long-term outcomes for individuals undergoing radical prostatectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prostate cancer patients treated with radical prostatectomy

Exclusion criteria

  • 1. Received neoadjuvant endocrine/chemotherapy before surgery;
  • 2. Urine leakage after surgery (positive creatinine test of drainage fluid).

Treatment and study plan

Primary outcomes

  1. dT-DNA Levels in Drainage Fluid

    Time frame: Measured daily for up to 3 days post-surgery

    Postoperative dT-DNA Levels in The Peritoneal Drainage Fluid

Study contacts

Contact information is provided by the study sponsor or research team.

Huaqi Zhan

CONTACT

[email protected]

18817532325

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Prognostic Study of Prostate Cancer Via Dynamic Change of Drainage Tumor DNA(dT-DNA) in Peritoneal Drainage Fluid After Radical Prostatectomy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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