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出境医 / 临床实验 / MEtatastic Renal Carcinoma LINes (MERLIN)

MEtatastic Renal Carcinoma LINes (MERLIN)

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
Renal Cell Carcinoma

Study Design
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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
Arms and Interventions
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date April 24, 2019
First Posted Date April 26, 2019
Last Update Posted Date April 30, 2019
Actual Study Start Date January 15, 2018
Actual Primary Completion Date October 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2019) 		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.
Original Primary Outcome Measures
 (submitted: April 24, 2019) 		Overall survival after the first line of treatment [ Time Frame: year 11 ]
Time ellapsed between initiation date for 2nd line treatment et the date of death, whatever the cause.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MEtatastic Renal Carcinoma LINes
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Renal Cell Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 24, 2019) 		440
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2019
Actual Primary Completion Date October 3, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03928964
Other Study ID Numbers P/2017/342
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor Centre Hospitalier Universitaire de Besancon
Collaborators Not Provided
Investigators
Principal Investigator: Benoit Rousseau, MD Hôpital Henri Mondor
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date April 2019

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