Clinical evaluation of a urinary biomarker for the early detection of clear cell renal carcinoma

Evaluation of urinary perilipin-1 (PLIN-1) as a Diagnostic biomarker in patients with clear renal cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12638739

Enrollment

110

Registered

2024-02-06

Start date

2023-05-18

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screening in patients with kidney cancer Cancer

Interventions

This is an analytical, case-control, prospective study that involves two experimental groups: a) Cases: patients diagnosed with kidney cancer who are going to undergo nephrectomy (partial or radical).

Eligibility

Sex/Gender

All

Age

18 Years to 150 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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) 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)	—

Measure

Time frame

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) 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)

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Chile

Contacts

Public ContactHugo;David Contador Otaola Arca;Martínez

;

hotaola@alemana.cl;dcontador@udd.cl+56 941089452;-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026