NCT03819569

Brief Summary

Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This study also incorporates integrated biomarker study to compare the genomic data obtained through biopsy tissue to genomic information from surgical data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 29, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

5.5 years

First QC Date

November 29, 2018

Last Update Submit

July 1, 2024

Conditions

Small Renal MassKidney Tumor

Keywords

genomic risk assessmentsmall renal mass

Outcome Measures

Primary Outcomes (3)

  • Change in Decisional Conflict

    Decisional conflict scale between patients who undergo renal mass biopsy, and who do not will be compared. Decisional conflict scale is a validated, 16-item instrument that measures personal perceptions of decision-making. It yields a total score from 0 to 100 (higher scores indicate more decisional conflict) and sub-scores for perceptions of uncertainty, informed values clarity, support, and effectiveness in decision-making.

    Baseline, 1-3 months (before treatment)

  • Receipt of nephrectomy

    The proportion of patients undergoing nephrectomy (radical and partial nephrectomy) between patients who undergo renal mass biopsy versus those who do not will be compared.

    1-3 months (index treatment), 2 years

  • Genomic mutations comparison

    Molecular subtype (ccA vs ccB) and the presence of genomic mutations between the renal mass biopsy and the surgical nephrectomy specimen will be compared.

    2 years

Secondary Outcomes (8)

  • Patient-reported anxiety

    Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months

  • Patient-reported cancer worry

    Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months

  • Patient-Reported Risk Perception

    Baseline, 1-3 months (before treatment)

  • Patient-reported uncertainty based on Short-Form Mishel Uncertainty of Illness Scale

    baseline, 1-3 months (before treatment)

  • Patient-reported regret about the decision

    6, 12, 18, 24 months

  • +3 more secondary outcomes

Study Arms (2)

Biopsy

ACTIVE COMPARATOR

Subjects receive a renal cell biopsy prior to making a decision about treatment

Procedure: Small Renal Mass Biopsy

No Biopsy

SHAM COMPARATOR

Subjects do not receive a renal cell biopsy prior to making a decision about treatment

Other: No Small Renal Mass Biopsy

Interventions

Small Renal Mass BiopsyPROCEDURE

Subjects will receive a small renal mass biopsy prior to making a treatment decision

Biopsy
No Small Renal Mass BiopsyOTHER

Subjects will not receive a small renal mass biopsy prior to making a treatment decision

No Biopsy

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 - 95
  • Have a small renal mass ≤7 cm on cross-sectional radiologic study evaluated at the University of North Carolina (UNC) Urology or the UNC Cancer Hospital.
  • Has voluntarily provided signed informed consent to participate and HIPAA authorization for the release of personal health information
  • Willing and able to complete patient-reported outcome questionnaires
  • Willing to have extra cores taken for research during the standard-of-care biopsy procedure
  • Willing to allow surgical specimens to be used for research
  • Willing to undergo a blood draw to evaluate for circulating tumor DNA

You may not qualify if:

  • Has staging information indicating locally advanced or metastatic disease.
  • Presence of transplant kidney
  • Unwilling or unable to complete informed consent
  • Previous biopsy of small renal mass.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Hung J Tan, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: non-randomized, comparative
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2018

First Posted

January 28, 2019

Study Start

October 30, 2018

Primary Completion

April 18, 2024

Study Completion

April 18, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)