NCT02848768

Brief Summary

The purpose of this study is to validate of a predictive nomogram of response or resistance to targeted therapies in metastatic clear cell renal cell carcinoma

Trial Health

80
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

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

December 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

July 26, 2016

Last Update Submit

July 27, 2016

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Primary refractory patients (Progression Free Survival (PFS)

    at 3 months

Interventions

SunitinibDRUG

Eligibility Criteria

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

cohort of 50 patients with metastatic ccRCC who underwent nephrectomy at the University Hospital of Rennes and treated by sunitinib first line treatment.

You may qualify if:

  • patients with metastatic ccRCC
  • Underwent nephrectomy at the University Hospital of Rennes
  • treated by sunitinib first line treatment

You may not qualify if:

  • translocation renal cell carcinoma
  • other targeted therapies before the sunitinib

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

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

Study Record Dates

First Submitted

July 26, 2016

First Posted

July 28, 2016

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

FR(1)