NCT03471897

Brief Summary

In this study, the investigators profiled plasma glycosaminoglycans (GAGs) in a retrospective consecutive series of patients with a radiographic finding of renal mass referred to primary surgery for renal cell carcinoma (RCC). A control group was formed by measuring plasma GAGs in healthy volunteers. The primary endpoints were the specificity and sensitivity of plasma GAGs in the detection of early stage RCC in pre-surgical samples versus healthy individuals. The investigators further analyzed how plasma GAGs varied according to stage, grade, RCC histology, other renal masses, and after surgery. Finally, the investigators estimated whether plasma GAGs could be used for prediction and surveillance of RCC recurrence.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

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 28, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

March 14, 2018

Last Update Submit

April 16, 2018

Conditions

Renal Cell Carcinoma

Keywords

glycosaminoglycansbiomarkersdiagnosticsprognosticliquid biopsy

Outcome Measures

Primary Outcomes (1)

  • Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals

    1 month

Secondary Outcomes (6)

  • Pearson correlation coefficient with plasma GAG score in pre-surgical samples and tumor size in cm

    1 month

  • Shift in plasma GAG score in pre-surgical samples between locally-advanced or advanced vs. localized RCC

    1 month

  • Shift in plasma GAG score in pre-surgical samples between Fuhrman Nuclear Grade 3+ vs. 2 in clear cell RCC.

    1 month

  • Shift in plasma GAG score in pre-surgical samples between clear cell vs. non-clear cell RCC

    1 month

  • Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for overall survival in RCC

    53 months

  • +1 more secondary outcomes

Study Arms (2)

RCC

Patients with pathologically confirmed diagnosis of RCC

Diagnostic Test: Glycosaminoglycan plasma score

Controls

Subjects self-reported as healthy

Diagnostic Test: Glycosaminoglycan plasma score

Interventions

Glycosaminoglycan plasma scoreDIAGNOSTIC_TEST

A score was calculated using a formula that factors in measurements of plasma glycosaminoglycan. A score higher than a here-determined threshold is deemed diagnostic of RCC.

ControlsRCC

Eligibility Criteria

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

Patients with pathologically confirmed diagnosis of RCC treated with surgical resection of the tumor

You may qualify if:

  • Patients with radiographic finding of renal mass referred to primary surgery;
  • Healthy volunteers without any history of malignancy.

You may not qualify if:

  • No records on date of surgery;
  • A pre-operative sample was obtained 50 days or earlier with respect to the date of surgery; - Absence of pre-operative samples following filtering out outliers or laboratory assay failures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gatto F, Blum KA, Hosseini SS, Ghanaat M, Kashan M, Maccari F, Galeotti F, Hsieh JJ, Volpi N, Hakimi AA, Nielsen J. Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma. Eur Urol Oncol. 2018 Oct;1(5):364-377. doi: 10.1016/j.euo.2018.04.015. Epub 2018 Jun 13.

    PMID: 31158075DERIVED

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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 21, 2018

Study Start

April 28, 2016

Primary Completion

October 25, 2017

Study Completion

January 18, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share