Can a protein found in urine, called perilipin-1, be used as a marker to diagnose kidney cancer?
| ISRCTN | ISRCTN12638739 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12638739 |
| Secondary identifying numbers | ID 1201 |
- Submission date
- 22/01/2024
- Registration date
- 06/02/2024
- Last edited
- 06/02/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
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?
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)
Who is the main contact?
Dr Hugo Otaola, hotaola@alemana.cl
Contact information
Public, Scientific, Principal Investigator
Las Hualtatas 5099, depto 203, Vitacura
Santiago
7630352
Chile
 ORCID ID |
0000-0003-4952-2283 |
|---|---|
| Phone | +56 941089452 |
| hotaola@alemana.cl |
Public
Las Hualtatas 5099, depto 203, Vitacura
Santiago
7630352
Chile
| Phone | +56 941089452 |
|---|---|
| hugotaolarca@hotmail.com |
Study information
| Study design | Analytical case-control prospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Diagnostic, Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | EvaluaTion Of urinaRy pErilipin-1 As a Diagnostic biOmarker in patients with kidney canceR |
| Study acronym | TOREADOR |
| Study hypothesis | 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 |
| Condition | 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 | 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 outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/04/2023 |
| Overall study end date | 31/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 150 Years |
| Sex | Both |
| Target number of participants | 110 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 18/05/2023 |
| Recruitment end date | 31/12/2025 |
Locations
Countries of recruitment
- Chile
Study participating centre
Santiago
7650568
Chile
Sponsor information
Hospital/treatment centre
Av Vitacura 5951
Santiago
7650568
Chile
| Phone | +56 222101111 |
|---|---|
| clinicaalemana@alemana.cl | |
| Website | https://www.clinicaalemana.cl/ |
"ROR" |
https://ror.org/028ynny55 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Clínica Alemana
- Location
- Spain
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Presentation of results at national and international conferences and publication in high-impact peer-reviewed journal |
| 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) |
Editorial Notes
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.
