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RecruitingOBSERVATIONAL

International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors

The i-RECORD study is an international project designed to understand the most effective ways to treat kidney cancer that hasn't spread. It's comparing several approaches: surgeries that remove part or all of the kidney, treatments that burn or freeze the tumour (ablation), and carefully watching the tumour (active surveillance). Although some treatments are standard, there's still a lot to learn about applying them to different patients, considering factors like age, other health conditions, and even local hospital resources. The study aims to gather high-quality information from many hospitals globally to help doctors make better, more personalised decisions for patients with kidney tumours, looking at outcomes like recovery, cancer control, and quality of life over 5-10 years.

At a glance

Status
Recruiting
Sponsor
Azienda Ospedaliero-Universitaria Careggi
Enrolment target
10,000
Start
10 Jan 2022
Estimated completion
31 Dec 2028

What is this study about?

This study, called i-RECORD, is a really important international project designed to help doctors understand the best ways to treat kidney cancer. When kidney cancer is found early and hasn't spread, there are several ways it can be managed. These include different types of surgery, such as removing just the part of the kidney with the tumour (partial nephrectomy) or the whole kidney (radical nephrectomy). There are also options like ablation therapy, where doctors use heat or cold to destroy the tumour, or active surveillance, where the tumour is carefully monitored without immediate treatment.

While some treatments are commonly used, doctors are still trying to figure out which approach is truly best for each individual. For example, for smaller tumours, partial surgery is often preferred, but how do we decide for more complicated cases? Also, for older patients or those with other health problems, alternative strategies like ablation or active surveillance might be better. This study will collect detailed information from many hospitals worldwide to see how these different treatments are used and what the long-term results are, including how they affect a patient's quality of life.

The main goal of i-RECORD is to fill in the gaps in our current knowledge. By looking at a large number of patients over several years, the study hopes to provide clear evidence that will help create better guidelines for kidney cancer care in the future. It's about making sure that every patient gets the most appropriate and effective treatment for their specific situation, considering not just the tumour, but also their overall health and well-being.

Key takeaways

  • The i-RECORD study aims to improve kidney cancer treatment globally.
  • It compares different treatments like surgery, ablation, and active surveillance.
  • Participation involves sharing medical information from your routine care.
  • Your treatment will not be changed by joining the study.
  • The study helps develop better guidelines for future patients.
  • Data will be collected over a period of 5 years.

Who may be eligible?

To be part of this study, you would need to have been diagnosed with a kidney tumour through scans, and your doctors believe it could be treated with surgery or monitored closely. You must also be 18 years of age or older.

Before joining, you'd need to agree to take part by signing a consent form. This ensures you understand what the study involves.

You wouldn't be able to join the study if you have a specific type of kidney cancer called urothelial renal carcinoma, or if you prefer not to participate in clinical research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have you been diagnosed with a kidney tumour that can be treated or watched?
  2. Are you 18 years old or older?
  3. Are you willing to sign a consent form to participate?
  4. Do you NOT have urothelial renal carcinoma (a specific type of kidney cancer)?
  5. Are you comfortable with your medical information being collected for research?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the i-RECORD study, your doctors will collect information about your kidney cancer and the treatment you receive. This will include details about your general health, the characteristics of your tumour from scans, the specific treatment you have and how it went, and laboratory results from any removed tissue.

After your treatment, the study team will continue to collect information about your health and recovery at specific follow-up appointments. These check-ups are usually scheduled at 6 months, 1 year, 2 years, and 5 years after your treatment. These appointments will be part of your regular medical care, and the study will simply be collecting data from them. The total duration of your participation in terms of data collection would be up to 5 years.

Potential risks and benefits

Taking part in this study won't change the kidney cancer treatment you receive, as your doctors will decide the best care for you independently. The potential benefit of participating is helping researchers gather important information that could improve kidney cancer treatment for future patients. There are no direct medical risks from participating in the study itself, as it only involves collecting information from your routine care. However, as with any medical treatment, there are always inherent risks associated with the treatments you receive. You are free to withdraw from the study at any time without affecting your medical care.

Locations (37)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Institute of Urology, University of Southern California.
    Verified postcode
    Los Angeles, United States· Recruiting
  • University of California San Diego, Moores Cancer Center
    Verified postcode
    San Diego, United States· Recruiting
  • Stanford University
    Verified postcode
    Stanford, United States· Not yet recruiting
  • Loyola University Medical Center, Edward Hines VA Hospital
    Verified postcode
    Chicago, United States· Not yet recruiting
  • University of Pennsylvania
    Verified postcode
    Philadelphia, United States· Not yet recruiting
  • VCU Health System
    Verified postcode
    Richmond, United States· Recruiting
  • Swedish Hospital
    Verified postcode
    Seattle, United States· Not yet recruiting
  • Medical University of Vienna, Vienna General Hospital
    Verified postcode
    Vienna, Austria· Recruiting
  • University of Bruxelles
    Verified postcode
    Brussels, Belgium· Recruiting
  • University Hospitals Leuven
    Verified postcode
    Leuven, Belgium· Not yet recruiting
  • Onze Lieve Vrouw Hospital
    Verified postcode
    Leuven, Belgium· Recruiting
  • Santa Casa da Misericórdia de Fortaleza
    Verified postcode
    Fortaleza, Brazil· Recruiting

Common questions

What is the main goal of this study?

The main goal is to find out which treatments for kidney cancer work best for different patients and improve future care guidelines worldwide.

Will my treatment be different if I join this study?

No, your treatment will be decided by your doctors based on what they believe is best for you, just as it would be if you weren't in the study.

What kind of information will the study collect about me?

The study will collect details about your health, tumour, treatment, and how you're doing at follow-up appointments over several years.

How long will I be involved in the study?

Data will be collected from your regular appointments for up to 5 years after your treatment.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it will not affect your medical care.

How to find out more

Marco Carini, Prof.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "International REgistry of COnservative or Radical Treatment …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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