MEtatastic Renal Carcinoma LINes (MERLIN)

Pronostic Assessment of Mortality Among Locally Advanced or Metastatic Renal Cell Carcinoma Patients After First Line Treatment : Multicenter Prospective Cohort Study With Historic Medical Data

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.

Study Overview

• Status: Unknown
• Conditions: Renal Cell Carcinoma

• Study Type: Observational
• Enrollment (Anticipated): 440

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • CHU de Besançon
  • Créteil, France
    • Hôpital Henri Mondor
  • Montbéliard, France
    • Hôpital Nord Franche-Comté Montbéliard
  • Paris, France
    • Institut Mutualiste Montsouris
  • Paris, France
    • Hôpital Saint-Louis
  • Paris, France
    • Hopital Cochin
  • Paris, France
    • Hôpital Européen Georges Pompidou
  • Saint-Mandé, France
    • Hopital d'Instruction des Armees de Begin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Benoit Rousseau, MD, Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): October 3, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: P/2017/342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No