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

ISRCTN	ISRCTN12638739
DOI	https://doi.org/10.1186/ISRCTN12638739
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	ID 1201
Sponsors	Clínica Alemana, Universidad del Desarrollo
Funder	Clínica Alemana de Santiago

Submission date: 22/01/2024
Registration date: 06/02/2024
Last edited: 25/11/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Kidney cancer (KC) is the third most common type of tumor in the urinary system for both men and women and sadly, it's also one of the top causes of cancer-related deaths. Right now, there's no reliable test to catch KC early. This study aims to change that by looking into whether a substance called Perilipin-1 in your urine could be a good sign that you might have KC, no matter what stage the cancer is at. In simpler terms, this study is trying to find a urine test that could help catch KC earlier than it is right now.

Who can participate?
Patients with KC and healthy controls aged 18 years old and over

What does the study involve?
The present study is an analytical, case-control, prospective study that considers two groups:
Cases: patients who have been diagnosed with KC at any stage who are going to undergo one of the following:
1. Surgical treatment (partial or radical nephrectomy).
2. Systemic treatment for KC with histological confirmation of renal cancer by percutaneous biopsy
Controls: healthy volunteers who undergo a preventive check-up where an image (ultrasound, CT, or MRI) excludes renal masses (benign or malignant).

Urine creatinine and PLIN-1 will be measured in urine samples at baseline (cases and controls) and six months after surgery (only for cases). The urine sample will be obtained from voided urine, except for the baseline sample of patients undergoing nephrectomy, which will be obtained by bladder catheterization on the day of surgery.

What are the possible benefits and risks of participating?
Participants will not receive any experimental therapy, and there will be no cost to participate in the study. Finding a urinary marker that allows population screening will permit early diagnosis of KC, which will imply a better oncological outcome.
No risks provided at the time of registration.

Where is the study run from?
Instituto de Ciencias e Innovación en Medicina (ICIM) (Santiago, Chile)
Centro de Medicina Regenerativa
Clinica Alemana (Santiago, Chile)

When is the study starting and how long is it expected to run for?
April 2023 to December 2026

Who is funding the study?
Clinica Alemana (Santiago, Chile)
Universidad del Desarrollo

Who is the main contact?
David Contador, PhD - dcontador@udd.cl
Rodrigo Acuña, PhD - rodrigoacuna@udd.cl
Hugo Otaola, PhD - hotaola@alemana.cl

Contact information

Dr Hugo Otaola Arca
Public, Scientific, Principal investigator

Las Hualtatas 5099, depto 203, Vitacura
Santiago
7630352
Chile

ORCID ID	0000-0003-4952-2283
Phone	+56 941089452
Email	hotaola@alemana.cl

Dr David Contador Martínez
Principal investigator, Public, Scientific

Avenida La Plaza 680, Las Condes
Santiago
7610315
Chile

ORCID ID	0000-0002-0383-214X
Email	dcontador@udd.cl

Dr Rodrigo Acuña Astudillo
Principal investigator, Scientific, Public

Avenida La Plaza 680, Las Condes
Santiago
7610315
Chile

ORCID ID	0000-0002-2033-3107
Email	rodrigoacuna@udd.cl

Study information

Primary study design	Observational
Study design	Analytical case-control prospective study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	Evaluation of urinary perilipin-1 (PLIN-1) as a Diagnostic biomarker in patients with clear renal cancer
Study acronym	TOREADOR
Study objectives	Urinary Perilipin-1 is a valid diagnostic biomarker of kidney cancer in all its stages.
Ethics approval(s)	Approved 24/04/2023, Comité Etico Científico de la Facultad de Medicina Clínica Alemana de Santiago-Universidad Del Desarrollo (Avda. La Plaza 680, Las Condes, Santiago, 7610658, Chile; None provided; ceccasudd@udd.cl), ref: 2023-25
Health condition(s) or problem(s) studied	Screening in patients with kidney cancer
Intervention	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). A urine sample (30 mL) will be obtained from a Folley catheter at the beginning of the kidney surgery. Additionally, a voided urine sample (30 mL) will be collected six months after surgery. b) Controls: healthy volunteers. A voided urine sample (30 mL) will be collected at the inclusion in the study.
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	31/12/2026

Eligibility

Participant type(s)	Healthy volunteer, Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	150 Years
Sex	All
Target sample size at registration	110
Key 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)
Key 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
Date of first enrolment	18/05/2023
Date of final enrolment	31/12/2025

Locations

Countries of recruitment

Chile

Study participating centre

Centro de Medicina Regenerativa, Instituto de Ciencias e Innovación en Medicina (ICIM)

Avenida la Plaza 680, Las Condes
Santiago
7610315
Chile

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository (www.redcap.alemana.cl)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/11/2025: The following changes were made to the study record:
1. The public title was changed from 'Can a protein found in urine, called perilipin-1, be used as a marker to diagnose kidney cancer?' to 'Clinical evaluation of a urinary biomarker for the early detection of clear cell renal carcinoma'.
2. The scientific title was changed from 'EvaluaTion Of urinaRy pErilipin-1 As a Diagnostic biOmarker in patients with kidney canceR' to 'Evaluation of urinary perilipin-1 (PLIN-1) as a Diagnostic biomarker in patients with clear renal cancer'.
3. The study participating centres and contacts were updated.
4. Universidad del Desarrollo was added as a funder.
17/10/2025: The following changes were made to the trial record:
1. The study participating centres were updated.
2. The plain English summary was updated to reflect these changes.
06/02/2024: The public title was changed from "Can a substance found in urine, called perilipin-1, be used as a marker to diagnose kidney cancer?" to "Can a protein found in urine, called perilipin-1, be used as a marker to diagnose kidney cancer?".
02/02/2024: Study's existence confirmed by the Department of Academic Development and Research and the Scientific Ethics Committee of the Faculty of German Clinic Medicine – Development University.