NCT02370290

Brief Summary

This pilot research trial studies quantitative imaging metrics derived from contrast enhanced computed tomography (CECT) in enhancing assessment of disease status in patients with kidney cancer. Quantitative imaging is the extraction of quantifiable features from radiological images for the assessment of disease status. Collecting quantitative imaging metrics from CECT imaging may help doctors predict tumor aggressiveness and nuclear grade (tumor stage) and assess treatment response and prognosis in cancer imaging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

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

April 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

February 17, 2015

Last Update Submit

March 1, 2016

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

  • Agreement between QIM predicted and pathologically determined tumor class (clear cell renal cell carcinoma [ccRCC] vs papillary [p]RCC)

    Cohen's kappa coefficient will be used to examine the agreement between QIM predicted and pathologically determined tumor class (ccRCC vs. pRCC).

    Baseline

  • Agreement between QIM predicted and pathologically determined tumor (Fuhrman) grade

    Examined using weighted kappa coefficient.

    Baseline

  • Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR

    Examined using two-way random single measure with absolute agreement.

    Baseline

  • Agreement between QIM predicted and clinical determined postoperative eGFR

    Examined using two-way random single measure with absolute agreement.

    Baseline

Study Arms (1)

Observational (QIM)

Patients' clinical and imaging data are collected from routine multiphase CECT imaging and used to establish and validate the classification/prediction rule for QIM.

Other: Medical Chart ReviewOther: Informational Intervention

Interventions

Medical Chart ReviewOTHER

Clinical and imaging information collected

Also known as: Chart Review
Observational (QIM)
Informational InterventionOTHER

Clinical and imaging data collected

Observational (QIM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients' clinical and imaging data from the University of Southern California/Norris Comprehensive Cancer Center and Keck Hospital.

You may qualify if:

  • Subjects with a renal mass who are scheduled for surgery for presumed RCC
  • Subjects scheduled for standard of care contrast enhanced CT examination at USC Norris Comprehensive Cancer Center
  • Subjects competent to sign study specific written informed consent

You may not qualify if:

  • Subjects who are pregnant
  • Subjects who cannot consent for themselves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

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

  • Vinay Duddalwar

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 24, 2015

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

US(1)