NCT03690895

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

1.6 years

First QC Date

September 26, 2018

Last Update Submit

September 28, 2018

Conditions

Central Nervous System LymphomaAIDS Related Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Median duration of survival after diagnosis of lymphoma (years)

    At the time of systematic files review (jan 2014) - average follow-up 7 years

Study Arms (1)

Cases

Other: Retrospective survival analysis

Interventions

Retrospective survival analysisOTHER

Kaplan-Meier model

Cases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • HIV infection
  • AIDS-related primary central nervous system lymphoma
  • treated with at least one infusion of methotrexate and combine antiretroviral therapy

You may not qualify if:

  • prior non-Hodgkin lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rotchschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Lymphoma, AIDS-Related

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 1, 2018

Study Start

March 15, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 1, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)