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Kidney cyst study may spare patients from unnecessary surgery

NCT ID NCT04558593

Knowledge-focused Sponsor: Université de Sherbrooke Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 330 adults with complex kidney cysts (Bosniak III or IV) for 5 years to compare cancer survival between those who have surgery and those who are monitored closely. The goal is to see if active surveillance is a safe alternative to surgery, which has risks like complications and even death. Participants must be 18+, have a new diagnosis, be symptom-free, and healthy enough for surgery if needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients incidentally diagnosed with a Bosniak III or IV cysts and who opted to be managed by either surgery or active surveillance

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years old and older; * diagnosed with a Bosniak III or IV cyst (classification 2019); * size of cystic component ≤7cm; * cyst wall/septum nodule (obtuse margin of protrusion) \<10mm (perpendicular axis) or nodular/solid component ≤2 cm in any axis; * life expectancy \>5 years (by physician's estimate); * new diagnosis ≤ 12 months from accrual date; * currently asymptomatic from the disease; * deemed fit enough for surgery; * willingness and ability to complete questionnaires in either French or English; * able and willing to provide informed consent Exclusion Criteria: * history of a hereditary renal cancer syndrome; * presence of polycystic kidney disease; * any prior history of RCC; * received systemic therapy for another malignancy within the 12 months prior to accrual; * uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction/unstable angina within 6 months that would predispose to immediate surgical therapy; * metastatic disease or evidence of vascular or nodal disease; * unwillingness to undergo monitoring and imaging studies; * any contra-indication(s) to contrast-enhanced imaging (estimated glomerular filtration rate \<30min/mL)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complex renal cyst

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Bordeaux (URO-CCR)

    RECRUITING

    Bordeaux, France

  • CHU de Québec - Université Laval

    RECRUITING

    Québec, Quebec, Canada

  • CHUM

    RECRUITING

    Montreal, Quebec, Canada

  • CIUSSS Mauricie-Centre-du-Québec

    RECRUITING

    Trois-Rivières, Quebec, Canada

  • Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis

    RECRUITING

    Lévis, Quebec, G6V 3Z1, Canada

  • Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)

    RECRUITING

    Montreal, Quebec, Canada

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, Canada

  • Mens Health Clinic

    RECRUITING

    Winnipeg, Manitoba, Canada

  • Northern Alberta Urology Center

    RECRUITING

    Edmonton, Alberta, T6G 1Z1, Canada

  • Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, Canada

  • Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • Prostate Cancer Center

    RECRUITING

    Calgary, Alberta, T2V 1P9, Canada

  • St-Joseph's Hospital

    RECRUITING

    Hamilton, Ontario, Canada

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, Canada

  • Thunder Bay Health Sciences Center

    RECRUITING

    Thunder Bay, Ontario, Canada

  • Vancouver Prostate Centre

    RECRUITING

    Vancouver, British Columbia, Canada

  • Woodstock hospital

    RECRUITING

    Woodstock, Ontario, Canada

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