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MERLIN: MEtatastic Renal Carcinoma LINes

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Unknown status
CT.gov ID
NCT03928964
Collaborator
(none)
440
Enrollment
8
Locations
14.5
Anticipated Duration (Months)
55
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    440 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jan 15, 2018
    Actual Primary Completion Date :
    Oct 3, 2018
    Anticipated Study Completion Date :
    Apr 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival after the first line of treatment [year 11]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Besançon Besançon France
    2 Hôpital Henri Mondor Créteil France
    3 Hôpital Nord Franche-Comté Montbéliard Montbéliard France
    4 Hôpital Cochin Paris France
    5 Hôpital Européen Georges Pompidou Paris France
    6 Hôpital Saint-Louis Paris France
    7 Institut Mutualiste Montsouris Paris France
    8 Hôpital d'Instruction des Armées de Bégin Saint-Mandé France

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    • Principal Investigator: Benoit Rousseau, MD, Henri Mondor University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT03928964
    Other Study ID Numbers:
    • P/2017/342
    First Posted:
    Apr 26, 2019
    Last Update Posted:
    Apr 30, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Apr 30, 2019