Clinical trial · Observational
The Natural History of Small Renal Masses
Role of Active Surveillance and Identification of Prognostic Factors for Progression in Early Stage Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is a rising incidence of incidentally detected small renal tumours due to improved imaging techniques. Traditionally, patients diagnosed with these small renal masses undergo surgery and therefore there is limited data about the natural history of these tumours. Several small series have reported that most of these small masses grow slowly and might not require early intervention and that only some masses grow rapidly requiring immediate surgery. Presently, the investigators have not been able to identify prospectively which masses are going to grow slowly. The investigators plan to use computed tomography (CT) and Magnetic Resonance Imaging (MRI) parameters, microsatellite analysis and tissue analysis to determine which masses will behave more aggressively. Additionally, the observations on the natural history of small renal masses need to be validated with a multicentric and systematically followed cohort.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Newly Diagnosed Small Renal Masses(<4cm) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumour progression:
- timeFrame
- 4 times year 1, 2 times year 2 and 3, yearly thereafter
- description
- i) calculated tumour volume doubles (100% increase) within any one-year period, and/or ii) the maximum tumour diameter reaches 4 cm., and/or iii) patients develop symptoms considered to be possibly due to their renal tumour and/or iv) patients develop metastases
Secondary outcomes (2)
- measure
- Time to Tumour Progression
- timeFrame
- 4 times year 1, 2 times year 2 and 3, yearly thereafter
- description
- Time to tumour progression will be measured from the date of diagnosis to the date of progression or, if progression has not occurred, until the date of last follow-up.
- measure
- Growth rate
- timeFrame
- 4 times year 1, 2 times year 2 and 3, yearly thereafter
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Asymptomatic T1a (\< 4.0 cm) renal mass and unfit for surgery due to advanced age or co-morbidity, OR * Asymptomatic T1a (\< 4.0 cm) and refusal of surgery * No evidence of metastatic disease (N0M0) * Preparedness to comply with a close follow-up protocol * Informed consent Exclusion Criteria: * Life expectancy \< 2 years * Already being followed for a small renal mass for more than 12 months * Concurrent systemic therapy for other malignancies * Known hereditary renal cancer syndromes
References
Publications (0)
Data not yet available