Can a protein found in urine, called perilipin-1, be used as a marker to diagnose kidney cancer?

Not Applicable

• Conditions: Screening in patients with kidney cancer; Cancer

• Registration Number: ISRCTN12638739
• Lead Sponsor: Clínica Alemana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-06
• Last Update Posted: 19 February 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Cases:
1. Patients = 18-yr, male or female
2. Diagnosed with kidney cancer at any stage
3. Who are willing to undergo one of the following:
3.1. Surgical treatment (partial or radical nephrectomy).
3.2. Systemic treatment for kidney cancer with histological confirmation of renal cancer by percutaneous biopsy

Controls:
1. Healthy volunteers, =18-yr old, male or female
2. Who undergo a preventive check-up where an image (ultrasound, CT or MRI) excludes renal masses (benign or malignant)

Exclusion Criteria

Cases:
1. Personal history of kidney surgery (for benign or malignant disease).
2. Current or recent treatment (<6 months) with chemotherapy, immunotherapy, or immune checkpoint inhibitors.
3. Clinical diagnosis of kidney cancer without histological confirmation

Controls:
1. Study in progress for possible kidney cancer
2. Personal history of kidney surgery, both for benign and malignant pathology
3. Current or recent treatment (<6 months) with chemotherapy, immunotherapy, or immune checkpoint inhibitors

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Creatinine (mg/dL) in urine samples measured with the modified JAFFE method, using the CREATININE DMSO kit (Applied Clinical Chemistry. S.A, Amposta, Spain) at baseline (cases and controls) and at six months after surgery (only for cases)<br>2. Perilipin-1 (PLIN-1) (ng/dL) in urine samples measured with a Sandwich ELISA assay using Human PLIN1/Perilipin Sandwich ELISA kit at baseline (cases and controls) and at six months after surgery (only for cases)<br>

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures