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MEtatastic Renal Carcinoma LINes (MERLIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03928964
Recruitment Status : Active, not recruiting
First Posted : April 26, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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
Renal Cell Carcinoma

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Study Type : Observational
Estimated 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 : January 15, 2018
Actual Primary Completion Date : October 3, 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Overall survival after the first line of treatment [ Time Frame: year 11 ]
    Time elapsed between initiation date for 2nd line treatment et the date of death, whatever the cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928964


Locations
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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, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Benoit Rousseau, MD Hôpital Henri Mondor

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03928964     History of Changes
Other Study ID Numbers: P/2017/342
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases