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
研究概览
详细说明
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/).
研究类型
注册 (预期的)
联系人和位置
学习地点
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BS
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Brescia、BS、意大利、25123
- 招聘中
- ASST Spedali Civili of Brescia
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接触：
- Simone Francavilla
- 电话号码：+390303995215
- 邮箱：simone.francavilla89@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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correlation between iXip and significant prostate carcer
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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correlation between iXip and tumor volume > 0.5 cm3
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Alessandro Antonelli、Spedali Civili Hospital, Brescia (Italy)
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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