NCT03928964

Brief Summary

The hypothesis of this study are as follows:

  • Prognostic evaluation of patients based on an integrative model provides better assessment of overall survival, and thus improves setting of care goals.
  • In a routine care population, antitumour drugs may have a significant impact on overall survival through their targeted antitumor effect, but also through their toxicity profile and their impact on comorbidities.
  • The optimization of patient support (supportive care, drug tolerance monitoring) can have an impact on the prognosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

8 active sites

Status
unknown

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

January 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

April 24, 2019

Last Update Submit

April 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival after the first line of treatment

    Time elapsed between initiation date for 2nd line treatment et the date of death, whatever the cause.

    year 11

Eligibility Criteria

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

Patients with locally advanced or metastatic renal cell carcinoma, whose first-line treatment included at least one anti-angiogenic agent (tyrosine kinase inhibitor or monoclonal antibodies) and / or an mTOR inhibitor

You may qualify if:

  • Patients with locally advanced or metastatic renal cell carcinoma
  • Whose first-line treatment included at least one anti-angiogenic agent (tyrosine kinase inhibitor or monoclonal antibodies) and / or an mTOR inhibitor;
  • Whatever was the overall ECOG-PS score (Eastern Cooperative Oncology Group Performance Status) at treatment initiation time
  • With first-line treatment carried out between 2007 and June 2016.

You may not qualify if:

  • Patient previously treated with only one cytokine (Interferon α2a, high-dose interleukin-2)
  • Refusal of processing of personal data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CHU de Besançon

Besançon, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Hôpital Nord Franche-Comté Montbéliard

Montbéliard, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Saint-Louis

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

Hôpital d'Instruction des Armées de Bégin

Saint-Mandé, France

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

  • Benoit Rousseau, MD

    Henri Mondor University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 26, 2019

Study Start

January 15, 2018

Primary Completion

October 3, 2018

Study Completion

April 1, 2019

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations