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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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/).
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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BS
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Brescia, BS, Italia, 25123
- Rekruttering
- ASST Spedali Civili of Brescia
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Ta kontakt med:
- Simone Francavilla
- Telefonnummer: +390303995215
- E-post: simone.francavilla89@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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correlation between iXip and significant prostate carcer
Tidsramme: 6 months after surgery
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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.
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6 months after surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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correlation between iXip and tumor volume > 0.5 cm3
Tidsramme: 6 months after surgery
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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 )
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6 months after surgery
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correlation between iXip and tumor volume > 2.5 cm3
Tidsramme: 6 months after surgery
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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 ).
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6 months after surgery
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correlation between iXip and Gleason Score >6
Tidsramme: 6 months after surgery
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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)
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6 months after surgery
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correlation between iXip and pathological stage > pT2
Tidsramme: 6 months after surgery
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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)
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6 months after surgery
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correlation between iXip and positive lymph node at final pathology specimens
Tidsramme: 6 months after surgery
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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)
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6 months after surgery
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Alessandro Antonelli, Spedali Civili Hospital, Brescia (Italy)
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PSA-IgM
Plan for individuelle deltakerdata (IPD)
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