Clinical trial · Observational
Correlation Between iXip and Final Pathology Specimen From Radical Prostatectomy: a Multicenter Prospective Trial
Correlation Between Immune compleX Predictive Index and Prostate Cancer Aggressiveness at Radical Prostetecomy Specimens: a Multicenter Prospective Trial
- 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)
The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm processes these parameters providing the probability of prostate cancer. Several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. Moreover, preliminary results from a prospective study showed that iXip could predict cancer aggressiveness, too.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune compleX Predictive Index | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- correlation between iXip and significant prostate carcer
- timeFrame
- 6 months after surgery
- description
- correlation between iXip and significant prostate carcer at final pathology specimens, defined as tumor volume \> 0.5 cm3 and Gleason scor equal or superior to 7. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (\>30%) should be associated with aggressive pathological features.
Secondary outcomes (5)
- measure
- correlation between iXip and tumor volume > 0.5 cm3
- timeFrame
- 6 months after surgery
- description
- clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (\>30%) should be associated with aggressive pathological features ( \>0.5cm3 tumor volume )
- measure
- correlation between iXip and tumor volume > 2.5 cm3
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria are: * histologically proven prostate cancer, * patients scheduled for radical prostatectomy * paziente able to provide consent * age \> 18 years or \< 80 years Exclusion criteria are: * neiadjuvant hormone therapy * salvage radical prostatectomy * concomitant solid or hematological tumors, * autoimmune disorders * or immunosuppressive therapies, * acute bacterial or viral infections.
References
Publications (0)
Data not yet available