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Application of new biomarkers based on plasma cfDNA detection in the monitoring of minimal residual disease (MRD) after prostatectomy: a single-center prospective study

Application of new biomarkers based on plasma cfDNA detection in the monitoring of minimal residual disease (MRD) after prostatectomy: a single-center prospective study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046279
Enrollment
Unknown
Registered
2021-05-12
Start date
2021-05-06
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

case series:Nil

Sponsors

Department of Urology, Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Male, aged <= 85 years; 2.Patients whose pathological diagnosis is prostate cancer; 3.The pathological stage of the patient after radical resection is greater than or equal to pT3b; 4.The patient's radical prostatectomy showed pathological pTN1 (pathologically confirmed lymph node metastasis); 5.Patients with metastatic prostate cancer (M1) that is clearly diagnosed by preoperative imaging; 6.The pathology of the patient after radical resection shows that the Gleason score is greater than or equal to 8; 7.The patient's expected survival time exceeds 12 months.

Exclusion criteria

Exclusion criteria: 1. Patients who have been diagnosed with any other malignant tumor within the past 5 years; 2. Patients with inoperable advanced metastatic prostate cancer; 3. Patients who have used anticoagulant and antiplatelet aggregation drugs for a long time (the anticoagulant has been stopped for less than 1 week); 4. Organ transplant subjects or previous non-autologous (allogeneic) bone marrow or stem cell transplant populations; 5. Subjects who have undergone blood transfusion 1 month before or during the operation; 6. At the same time suffering from other serious systemic diseases, which the investigator believes may interfere with the treatment, evaluation and compliance of this test, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary and other systems disease; 7. Patients who are participating in other clinical trials, or who have participated in other clinical trials and have been completed for less than one year; 8. Patients who are judged by the investigator to be unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Blood cfDNA detection;Demographic data (sex, age, etc.), past medical history, family medical history and pathological diagnosis (pathological type, TNM staging);Adverse events;Positive rate of incision margin, no recurrence timeof Biochemistry after operation, urine control afteroperation, recovery rate of sexual function afteroperation, quality of life scale, OS, endocrineadverse reactions;Postoperative follow-up information and imaging examination results;

Countries

China

Contacts

Public ContactRen Shancheng

Department of Urology, Shanghai Changhai Hospital

renshancheng@gmail.com+86 13917793885

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026