- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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/).
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Alessandro Antonelli
- 전화번호: +390303995215
- 이메일: alessandro_antonelli@me.com
연구 장소
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BS
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Brescia, BS, 이탈리아, 25123
- 모병
- ASST Spedali Civili of Brescia
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연락하다:
- Simone Francavilla
- 전화번호: +390303995215
- 이메일: simone.francavilla89@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
correlation between iXip and significant prostate carcer
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
correlation between iXip and tumor volume > 0.5 cm3
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Alessandro Antonelli, Spedali Civili Hospital, Brescia (Italy)
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PSA-IgM
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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