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

NCT06707974 | Not Yet Recruiting

• 1 other identifier: YLY-dT DNA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasms; ctDNA

Outcome Measures

Primary Outcomes (1)

• dT-DNA Levels in Drainage Fluid

  Postoperative dT-DNA Levels in The Peritoneal Drainage Fluid

  Measured daily for up to 3 days post-surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include male patients diagnosed with prostate cancer who need radical prostatectomy. Participants must have a preoperative diagnosis confirmed by biopsy and imaging studies. Eligible patients will have an abdominal drainage system in place post-surgery for fluid collection.

You may qualify if:

• Prostate cancer patients treated with radical prostatectomy

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

In this study, biospecimens consist of peritoneal drainage fluid of patients following radical prostatectomy. The fluid is obtained through standard post operative drainage procedures. The collected samples are analyzed to measure the levels of dT-DNA over a designated post-surgical period. The dT-DNA levels in the drainage fluid are dynamically monitored and recorded to assess potential correlations with patient outcomes, recurrence, and metastasis.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Huaqi Zhan

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

  STUDY CHAIR

Central Study Contacts

Huaqi Zhan

CONTACT

18817532325; 0HuaChang@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: November 27, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)