MEtatastic Renal Carcinoma LINes

Renal Cell Carcinoma Clinical Trial

— MERLIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03928964
• Other study ID #: P/2017/342
• Status: Active, not recruiting
• Start date: January 15, 2018
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: April 2019
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a2a, high-dose interleukin-2)

2. Refusal of processing of personal data

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	Hôpital Henri Mondor	Créteil
France	Hôpital Nord Franche-Comté Montbéliard	Montbéliard
France	Hôpital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Saint-Louis	Paris
France	Institut Mutualiste Montsouris	Paris
France	Hôpital d'Instruction des Armées de Bégin	Saint-Mandé

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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