The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Kidney Neoplasm

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT02346435

17821

850179 (Other Identifier)

NA_00016036

Details and patient eligibility

About

Retrospective studies indicate that active surveillance for clinically localized, small renal masses (cT1a, <=4cm) is safe. It is our hypothesis that active surveillance is safe and efficacious when compared prospectively to patients undergoing immediate intervention for their small renal mass.

Full description

All patients are offered active surveillance or immediate intervention, as applicable, prior to being offered consent for the DISSRM Registry. All patients are enrolled and followed prospectively. Surveillance patients are followed per protocol with serial imaging, blood work and quality of life questionnaires. Intervention patients are followed at the discretion of the attending surgeon with serial QOL appointments/questionnaires.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must have a solid, enhancing renal mass ≤4cm at its greatest dimension found on incidental scanning in the last 6 months.
• Age ≥ 18 and able to read, understand and sign informed consent.
• Must be willing to adhere to the treatment algorithm and time constraints therein.

Exclusion criteria

• Cannot have suspicion of metastases to the kidney if any other malignancy diagnosed within two years of study entry.

Trial design

600 participants in 3 patient groups

Active Surveillance

Immediate Intervention

Description:

May include patients undergoing open or minimally-invasive partial nephrectomy, radical nephrectomy or energy ablation.

Crossover (Delayed Intervention)

Description:

Initially patients in active surveillance that meet progression criteria or elect to undergo delayed intervention.