Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
280 participants
OBSERVATIONAL
2020-12-01
2024-07-01
Brief Summary
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Detailed Description
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The Secretory leukocyte protease inhibitor (SLPI) is a serine protease which best-defined function is to protect host tissues from the excessive damage by proteolytic enzymes released during inflammation. Recently SLPI has been found overexpressed in a variety of cancers (pancreatic, papillary thyroid, uterine cervix, endometrial, and ovarian cancer). In apparent contrast, SLPI has been found reduced in the sera (and tumor tissue) of prostate cancer patients in the respect of healthy subjects and of subjects with benign hyperplasia. However, SLPI has been found upregulated in castration resistant prostate cancer (CRPC) patients and in a subset of CRPC cell lines.
These data suggest that expression of SLPI in prostate cancer could be biphasic: underexpressed during the early stages and overexpressed during progression. This peculiar pattern of SLPI expression suggests that SLPI may play a role in prostate cancer pathogenesis and/or in determining its neoplastic features. In this respect, it is noteworthy that SLPI is located at 20q13.2 (HPC20 locus), a locus harboring prostate cancer susceptibility genes. Based on these data it is possible to hypothesize that prostate cancer progression could be associated, and possibly heralded, by the increase of SLPI.
This is an observational investigation of SLPI levels in blood and tissue samples of patients with prostate disease with the explorative goal to verify whether SLPI could be a potential biomarker of prostate cancer progression.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case
200 patients with a suspicion of prostate cancer
Secretory leukocyte protease inhibitor (SLPI) in prostate cancer
7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the "Human SLPI Quantikine ELISA Kit". SLPI level will be measured at diagnosis and during the follow-up (3, 9, 15 months and in case of progression).
Immunohistochemistry protocol for SLPI immunostaining to investigate SLPI levels prostate tissue
Determination of molecular alterations
The presence of ETS translocation (or of ETS overexpression) will be tested on bioptic samples in each patient as for routine diagnostic procedures. First, ERG overexpression will be investigated by ERG immunostaining. The samples negative for ERG immunostaining will be studied for TMPRSS2-ERG translocation either by in situ FISH or by a translocation-specific RT-PCR. Next, the biopsies negative for TMPRSS2-ERG will be tested for the overexpression of other ETS proteins (ETV1, ETV4, ETV5 and for others rarely occurring ETS). When possible, it will be determined the status of pTEN gene, the tumor suppressor most frequently lost in prostate patients. The patients negative for the overexpression of the ETS proteins will be tested for SPINK1.
Control A
(a) 50 patients with benign prostate hyperplasia (BPH)
Determination of molecular alterations
The presence of ETS translocation (or of ETS overexpression) will be tested on bioptic samples in each patient as for routine diagnostic procedures. First, ERG overexpression will be investigated by ERG immunostaining. The samples negative for ERG immunostaining will be studied for TMPRSS2-ERG translocation either by in situ FISH or by a translocation-specific RT-PCR. Next, the biopsies negative for TMPRSS2-ERG will be tested for the overexpression of other ETS proteins (ETV1, ETV4, ETV5 and for others rarely occurring ETS). When possible, it will be determined the status of pTEN gene, the tumor suppressor most frequently lost in prostate patients. The patients negative for the overexpression of the ETS proteins will be tested for SPINK1.
Secretory leukocyte protease inhibitor (SLPI) Healthy
SLPI level will be measured also in the serum and in the urine from controls (patients with BPH and healthy subjects).
7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the "Human SLPI Quantikine ELISA Kit".
Control B
(b) 30 male subjects older than 50 years with neither prostate disease nor any other neoplasia
Secretory leukocyte protease inhibitor (SLPI) Healthy
SLPI level will be measured also in the serum and in the urine from controls (patients with BPH and healthy subjects).
7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the "Human SLPI Quantikine ELISA Kit".
Interventions
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Secretory leukocyte protease inhibitor (SLPI) in prostate cancer
7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the "Human SLPI Quantikine ELISA Kit". SLPI level will be measured at diagnosis and during the follow-up (3, 9, 15 months and in case of progression).
Immunohistochemistry protocol for SLPI immunostaining to investigate SLPI levels prostate tissue
Determination of molecular alterations
The presence of ETS translocation (or of ETS overexpression) will be tested on bioptic samples in each patient as for routine diagnostic procedures. First, ERG overexpression will be investigated by ERG immunostaining. The samples negative for ERG immunostaining will be studied for TMPRSS2-ERG translocation either by in situ FISH or by a translocation-specific RT-PCR. Next, the biopsies negative for TMPRSS2-ERG will be tested for the overexpression of other ETS proteins (ETV1, ETV4, ETV5 and for others rarely occurring ETS). When possible, it will be determined the status of pTEN gene, the tumor suppressor most frequently lost in prostate patients. The patients negative for the overexpression of the ETS proteins will be tested for SPINK1.
Secretory leukocyte protease inhibitor (SLPI) Healthy
SLPI level will be measured also in the serum and in the urine from controls (patients with BPH and healthy subjects).
7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the "Human SLPI Quantikine ELISA Kit".
Eligibility Criteria
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Inclusion Criteria
* Patients with Benign Prostatic Hyperplasia.
* Male subjects older that 50 years without prostate or neoplastic diseases.
Exclusion Criteria
* Male subjects with neoplastic diseases either than prostate.
18 Years
MALE
No
Sponsors
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Istituto per lo Studio, la Prevenzione e la Rete Oncologica
OTHER
Azienda Ospedaliero-Universitaria Careggi
OTHER
University of Florence
OTHER
Responsible Party
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Simone Morselli
PhD Student
Principal Investigators
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Rosario Notaro, MD
Role: PRINCIPAL_INVESTIGATOR
ISPRO
Locations
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Careggi University Hospital
Florence, Tuscany, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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17931
Identifier Type: -
Identifier Source: org_study_id
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