- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04859920
Living Conditions of Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma in the Côte d'Or Region (LymphoVi)
April 22, 2021 updated by: Centre Hospitalier Universitaire Dijon
The development of new diagnostic tools and targeted therapy have significantly improved the management of non-Hodgkin's malignant lymphomas and thus their long-term prognosis.
However, in the study of improved patient management, survival is not the only measurable indicator and preservation of quality of life is an essential component.
In addition, there is little existing data regarding the determinants of quality of life in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) in the general population in France.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
159
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marc Maynadié
- Phone Number: 03 80 39 34 16
- Email: marc.maynadie@u-bourgogne.fr
Study Locations
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Dijon, France, 21000
- Chu Dijon Bourogne
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Contact:
- Marc Maynadié
- Phone Number: 03 80 39 34 16
- Email: marc.maynadie@u-bourgogne.fr
-
-
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
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Diffuse large cell diffuse B lymphoma Follicular Lymphoma
Description
Inclusion Criteria:
- Patients diagnosed with DLBCL or FL between January 1, 2010 and December 31, 2017,
- Alive as of January 1, 2021,
- Updated patient address.
Exclusion Criteria:
- Other forms of Hematologic Malignancies at diagnosis,
- Minors.
- Person subject to legal protection (curatorship, guardianship)
- Person subject to a judicial safeguard measure
- Pregnant, parturient or breastfeeding woman
- Adults incapable of giving consent
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Generic Questionnaire SF-12
Time Frame: At inclusion
|
At inclusion
|
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Specific questionnaire QLQ-C30
Time Frame: At inclusion
|
At inclusion
|
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 (Anticipated)
May 1, 2021
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
May 1, 2022
Study Registration Dates
First Submitted
April 22, 2021
First Submitted That Met QC Criteria
April 22, 2021
First Posted (Actual)
April 26, 2021
Study Record Updates
Last Update Posted (Actual)
April 26, 2021
Last Update Submitted That Met QC Criteria
April 22, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAYNADIE 2020
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.