- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413007
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Since the 90s, serum PSA has become the cornerstone of diagnosis of PCa, However, due to its proven poor specificity, the actual role of PSA testing has been largely debated, especially if used during opportunistic screening programs. leading to a significant risk of over-diagnosis and over treatment.
In order to overcome drawbacks of PSA-based diagnostic pathway several PSA-derivates has been proposed. However, they were marginally used in clinical practice because not supplied by public health care systems.
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.
All pathological specimens are analyzed by an expert uropathologist, following ISUP reccomandations.
Before radical prostectomy a blood sample from each patients is collected. Serum PSA-IgM concentration is measured using Prostate-IC kit in duplicate. The analysis with Prostate-IC kit was performed on automated ELISA analyzer.Then the iXip index is calculated by using the online calculator (http://ixip.xeptagen.com/).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alessandro Antonelli
- Phone Number: +390303995215
- Email: alessandro_antonelli@me.com
Study Locations
-
-
BS
-
Brescia, BS, Italy, 25123
- Recruiting
- ASST Spedali Civili of Brescia
-
Contact:
- Simone Francavilla
- Phone Number: +390303995215
- Email: simone.francavilla89@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between iXip and significant prostate carcer
Time Frame: 6 months after surgery
|
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.
|
6 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between iXip and tumor volume > 0.5 cm3
Time Frame: 6 months after surgery
|
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 )
|
6 months after surgery
|
correlation between iXip and tumor volume > 2.5 cm3
Time Frame: 6 months after surgery
|
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 ( >2.5cm3 tumor volume ).
|
6 months after surgery
|
correlation between iXip and Gleason Score >6
Time Frame: 6 months after surgery
|
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 ( Gleason Score> 6)
|
6 months after surgery
|
correlation between iXip and pathological stage > pT2
Time Frame: 6 months after surgery
|
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 ( pathological staging >pT2)
|
6 months after surgery
|
correlation between iXip and positive lymph node at final pathology specimens
Time Frame: 6 months after surgery
|
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 ( positive lymph nodes >0)
|
6 months after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alessandro Antonelli, Spedali Civili Hospital, Brescia (Italy)
Study record dates
Study Major Dates
Study Start (Actual)
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
- PSA-IgM
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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