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SLPI for Prostate Cancer

NCT04854343 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 280

Last updated 2022-05-09

No results posted yet for this study

Summary

Exploratory study of SLPI expression in human prostate cancer patients This is a no-profit exploratory study about the expression of SLPI in human prostate cancer patients that will enroll about 200 patients admitted for suspect prostate cancer to Careggi University Hospital. We will verify whether an increase SLPI levels in the sera may serve as biomarker of cancer progression.

Conditions

Interventions

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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".

Sponsors & Collaborators

  • Istituto per lo Studio, la Prevenzione e la Rete Oncologica

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Careggi

    collaborator OTHER

  • University of Florence

    lead OTHER

Principal Investigators

  • Rosario Notaro, MD · ISPRO

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-01
Completion
2024-07-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04854343 on ClinicalTrials.gov