Recruiting

Observational Study

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT02346435

Conditions

Kidney Neoplasm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Kidney Neoplasm

Study ID

NCT02346435

Start date

Jan, 2009

Status verified date

Sep, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Active Surveillance

Immediate Intervention

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

Crossover (Delayed Intervention)

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

Primary outcome measure

  • Disease-specific survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Nirmish Singla

410-502-3692nsingla2@jhmi.edu

Tina Driscoll

twlajni1@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Phillip M Pierorazio, MD

4105025984philpierorazio@jhmi.edu

Principal Investigator:

Mohamad E Allaf, MD, MBA

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Mar 5, 2026

Last verified

Sep, 2025

Keywords

  • small renal mass
  • active surveillance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-03-05.