Renal Cell CarcinomaMERLINNCT03928964
MEtatastic Renal Carcinoma LINes
An observational study of Renal Cell Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 440 participants
- Where
- 8 sitesFrance
- Study dates
- 15 Jan 2018to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
- Whatever was the overall ECOG-PS score (Eastern Cooperative Oncology Group Performance Status) at treatment initiation time
- With first-line treatment carried out between 2007 and June 2016.
Who cannot join
- Patient previously treated with only one cytokine (Interferon α2a, high-dose interleukin-2)
- Refusal of processing of personal data
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU de Besançon
Besançon
Hôpital Henri Mondor
Créteil
Hôpital Nord Franche-Comté Montbéliard
Montbéliard
Hôpital Cochin
Paris
Hôpital Européen Georges Pompidou
Paris
Hôpital Saint-Louis
Paris
Institut Mutualiste Montsouris
Paris
Hôpital d'Instruction des Armées de Bégin
Saint-Mandé
About this study
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
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.
- Conditions
- Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: year 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start15 Jan 2018
- Primary completion3 Oct 2018
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Rousseau, MD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928964
- Sponsor's protocol ID
- P/2017/342
- Acronym
- MERLIN
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03928964
- Acronym / sponsor ID
- MERLIN / P/2017/342
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- Apr 2019 (estimated)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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;
- Whatever was the overall ECOG-PS score (Eastern Cooperative Oncology Group Performance Status) at treatment initiation time
- With first-line treatment carried out between 2007 and June 2016.
Key exclusion criteria (2 listed)
- Patient previously treated with only one cytokine (Interferon α2a, high-dose interleukin-2)
- Refusal of processing of personal data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Rousseau, MD principal investigator
Henri Mondor University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival after the first line of treatment (time frame: year 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.