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

NCT ID: NCT06707974

Last Updated: 2024-11-27

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

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostatic Neoplasms ctDNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Liu Cheng

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huaqi Zhan

Role: STUDY_CHAIR

https://www.shgh.cn/home/index.html

Locations

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Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Huaqi Zhan

Role: CONTACT

[email protected]
18817532325

Other Identifiers

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YLY-dT DNA

Identifier Type: -

Identifier Source: org_study_id