Clinical trial · Observational
Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level
NCT03488706CI-TRIAL-00032381unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Gray Zone Group
- description
- The gray zone group PSA between 4.00 to 10.99 ng/ml.
Primary outcomes (1)
- measure
- Circulating tumor cells detection
- timeFrame
- Prior to prostate biopsy
- description
- Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA "gray zone" level
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects are willing to sign the informed consent and agree to comply with the study procedures. * Age from 20 to 99 years old * Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months Exclusion Criteria: * Age \< 20 years * Refuse to sign the informed consent form * Received regional anesthesia and general anesthesia within one month * Previous cancer history * Autoimmune diseases * Chronic inflammatory diseases * Diagnosed with colorectal polyps or adenomas * Acute inflammatory or infectious diseases in three months * Other diseases decided by PI
References
Publications (0)
Data not yet available
No reference posted for this study.