Success of active surveillance in patients with untreated small renal masses with the option of delayed treatment.

Study ID
STU 032014-064

Study Sites

  • Clements University Hospital

Contact
Allison Beaver
214/645-8788
ALLISON.BEAVER@UTSouthwestern.edu

Principal Investigator
Vitaly Margulis, M.D.

Summary

This is a prospective, non-randomized, non-blinded observational study to determine the oncologic, renal function and quality of life outcomes of active surveillance in patients with small renal masses [LessThanorequalTo]4cm. Further, the study will evaluate growth kinetics and biologic behavior of untreated small renal masses as well as the utility of multi-parametric magnetic resonance imaging (mp-MRi) in prediction of histologic tumor characteristics and subsequent clinical behavior. Quality of life will be monitored at baseline and over the course of the study via validated questionnaires. Patient tissue and blood will be obtained to study molecular mechanisms involved in cancer progression.

Participant Eligibility

1. Patients aged >=18 years and ECOG performance status 0-3.
2. Presence of a renal mass <=4cm with a solid enhancing component, clinical stage cT1a, cN0, cM0 (confirmed by cross-sectional imaging of the abdomen and a radiograph or computed tomography of the chest).
3. Patients willing to undergo AS or unfit for active treatment but without tumor related symptoms.
4. Patients willing to undergo tissue biopsy of the SRM (not mandatory but strongly encouraged)