- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02951871
Causes of Death in Follicular Lymphoma: a Single Center Retrospective Analysis
November 8, 2016 updated by: Hospices Civils de Lyon
Background.Although the life expectancy of patients with FL has recently increased, notably since the introduction of rituximab in combination with chemotherapy, little is known regarding the precise causes of patients death.
Patients and methods'.
This study describes the different causes of death in FL patients among followed since 2000 at Lyon University Hospital, centre Léon Bérard and Mayo Clinic.
The causes of death will be classified as related to lymphoma progression, treatment-related toxicity (including TRM and secondary myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
237
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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Rhône Alpes
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Pierre Bénite, Rhône Alpes, France, 69126
- Centre Hospitalier Lyon Sud
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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
This retrospective analysis was performed in 3 reference center where patients were treated and regularly followed for FL between January 2000 and December 2015.
All patients were initially staged according to the conventional recommendations, including a clinical examination and blood tests, a bone marrow biopsy, and a computerized tomography body scan.
The treatment modalities have evolved over time and were chosen according to the institutional guidelines.
Description
Inclusion Criteria:
- FL patients
- patients recorded as deceased
Exclusion Criteria:
-Other diagnosis than FL
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
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
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LP: Lymphoma Progression
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TRM: Treatment Related Mortality
|
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NHM: Non hematologic malignancy
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OC: Other Cause
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
overall survival (OS)
Time Frame: OS length was calculated from the date of diagnosis to the date of death
|
OS length was calculated from the date of diagnosis to the date of death
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2000
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
October 31, 2016
First Submitted That Met QC Criteria
October 31, 2016
First Posted (Estimate)
November 1, 2016
Study Record Updates
Last Update Posted (Estimate)
November 9, 2016
Last Update Submitted That Met QC Criteria
November 8, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0719
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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