- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03690895
Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy (LCPVIH)
September 28, 2018 updated by: Fondation Ophtalmologique Adolphe de Rothschild
This study aims at describing survival rates over time (Kaplan-Meier estimator) in patients suffering from AIDS-related primary central nervous system lymphoma who were diagnosed from 1996 to 2014 and treated with infusions of high-dose methotrexate and combined antiretroviral therapy.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France, 75019
- Fondation Ophtalmologique A. de Rotchschild
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients treated for AIDS-related primary central nervous system lymphoma in Fondation Rothschild (Paris, France) between january1996 and december 2014
Description
Inclusion Criteria:
- HIV infection
- AIDS-related primary central nervous system lymphoma
- treated with at least one infusion of methotrexate and combine antiretroviral therapy
Exclusion Criteria:
- prior non-Hodgkin lymphoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cases
|
Kaplan-Meier model
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Median duration of survival after diagnosis of lymphoma (years)
Time Frame: At the time of systematic files review (jan 2014) - average follow-up 7 years
|
At the time of systematic files review (jan 2014) - average follow-up 7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
September 26, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (Actual)
October 1, 2018
Study Record Updates
Last Update Posted (Actual)
October 1, 2018
Last Update Submitted That Met QC Criteria
September 28, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI_2015_2_AMR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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