- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369508
PD-L1-expressing Regulatory T Cells in Localized Prostate Cancer Patients Undergoing Iodine-125 Permanent Brachytherapy
PD-L1-expressing Regulatory T Cells in Blood and Urine of Localized Prostate Cancer Patients Undergoing Iodine-125 Permanent Brachytherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Permanent brachytherapy is one of those standard treatments for localized prostate cancer patients.
Biopsy confirms prostate cancer. Blood and urine of localized prostate cancer patients will be collected before and at different time points after permanent brachytherapy (1, 3, 6, and 12 months)
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Tongwen Ou, MD.
- Phone Number: +8617801117318
- Email: outongwen1967@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Biopsy confirms prostate cancer
Localized Prostate Cancer, ≤cT3
No chemotherapy or Hormonal therapy before Permanent Brachytherapy
Exclusion Criteria:
- Unacceptable operative risk
Poor anatomy which in the opinion of the radiation oncologist could lead to a suboptimal implant (e.g.,large or poorly healed transurethral resection of the prostate (TURP) defect, large median lobe, large gland size).
Pathologically positive lymph nodes
Significant obstructive uropathy
Distant metastases
Use steroids regularly
The diagnosis was accompanied by immune-related diseases
Allergic constitution
Abnormal white blood cell and lymphocyte counts
Ever underwent other treatments for prostate cancer, such as chemotherapy or Hormonal therapy
Accompanied by other malignancies
Splenectomy
HIV positive
Receive an anti-infective vaccine for the last 6 months
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the level of PD-L1-expressing regulatory T cells in blood and urine
Time Frame: 2 year
|
the level of PD-L1-expressing regulatory T cells in blood and urine
|
2 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tongwen Ou, MD., Xuanwu Hospital, Beijing
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200428003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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