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Trial record 83 of 149 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

Correlation Between iXip and Final Pathology Specimen From Radical Prostatectomy: a Multicenter Prospective Trial

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ClinicalTrials.gov Identifier: NCT03413007
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Alessandro Antonelli, Azienda Ospedaliera Spedali Civili di Brescia

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Diagnostic Test: Immune compleX Predictive Index

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/).


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Immune compleX Predictive Index and Prostate Cancer Aggressiveness at Radical Prostetecomy Specimens: a Multicenter Prospective Trial
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Diagnostic Test: Immune compleX Predictive Index
    iXip is an algorithm thant integrates PSA, PSA-IgM, prostate volume and age of the patient in order to provide the probability of prostate cancer


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 )

  2. 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 ).

  3. 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)

  4. 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)

  5. 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)


Biospecimen Retention:   Samples Without DNA
a blood serum sample will be stored for each patient


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients with prostate cancer scheduled for radical prostatectomy
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413007


Contacts
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Contact: Alessandro Antonelli +390303995215 alessandro_antonelli@me.com

Locations
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Italy
ASST Spedali Civili of Brescia Recruiting
Brescia, BS, Italy, 25123
Contact: Simone Francavilla    +390303995215    simone.francavilla89@gmail.com   
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
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Principal Investigator: Alessandro Antonelli Spedali Civili Hospital, Brescia (Italy)

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Responsible Party: Alessandro Antonelli, Urology consultant, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03413007     History of Changes
Other Study ID Numbers: PSA-IgM
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Antigen-Antibody Complex
Immunologic Factors
Physiological Effects of Drugs