The objective of this study is to define the natural history of small, incidentally detected, histologically confirmed RCCs and the oncological outcomes of an active surveillance approach for this category of renal tumors in a prospective, multi-…
Bron
Verkorte titel
Aandoening
Renal Cell Carcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Overall survival
Achtergrond van het onderzoek
A total of 400 patients with small, incidentally detected, histologically confirmed Renal Cell Carcinoma (RCC) will be included and data related to the oncological outcomes of an active surveillance approach will be collected. The primary objective of this study is to assess overall survival of patients who are diagnosed with incidental, histologically (biopsy) confirmed, <4 cm RCC and are managed conservatively with active surveillance.
Doel van het onderzoek
The objective of this study is to define the natural history of small, incidentally detected, histologically confirmed RCCs and the oncological outcomes of an active surveillance approach for this category of renal tumors in a prospective, multi-national clinical registry study.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Active surveillance approach
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
o Males or females, age ≥ 18 years.
o Incidental diagnosis at imaging (ultrasonography, CT, MRI) of a solid renal mass < 4 cm in maximum diameter (pT1a).
o Histologically confirmed RCC by percutaneous needle biopsy at diagnosis. All RCC subtypes are eligible for the study.
o Patients unfit for active treatment due to advanced age, or co-morbidity, or choosing to avoid active treatment.
o Signed Informed consent.
o Preparedness to comply with percutaneous tumor biopsy and a close follow-up protocol
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
o Renal tumors with a non-RCC histology (sarcomas, lymphomas, etc.).
o Presence of metastatic disease at diagnosis
o Tumor related symptoms at presentation.
o Patients with known genetic diseases associated with RCC (VHL, BHD, HLRCC, etc.).
o Patients unsuitable for biopsy due to need for concomitant anticoagulation or anti-platelet drug use which cannot be transiently discontinued.
o Patients unsuitable for biopsy due to tumor location or small tumor size.
o Patients with concurrent systemic treatment for another cancer.
o Patients with estimated life expectancy < 1 year.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7485 |
Ander register | EAU Research Foundation : EAU-RF 2015-01 |